US20130079618A1 - Technique for remanufacturing a bis sensor - Google Patents
Technique for remanufacturing a bis sensor Download PDFInfo
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- US20130079618A1 US20130079618A1 US13/245,040 US201113245040A US2013079618A1 US 20130079618 A1 US20130079618 A1 US 20130079618A1 US 201113245040 A US201113245040 A US 201113245040A US 2013079618 A1 US2013079618 A1 US 2013079618A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6839—Anchoring means, e.g. barbs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/04—Constructional details of apparatus
- A61B2560/0475—Special features of memory means, e.g. removable memory cards
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
- A61B2562/0215—Silver or silver chloride containing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
- A61B2562/0217—Electrolyte containing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
- A61B2562/125—Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/6813—Specially adapted to be attached to a specific body part
- A61B5/6814—Head
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49718—Repairing
- Y10T29/49721—Repairing with disassembling
- Y10T29/4973—Replacing of defective part
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49718—Repairing
- Y10T29/49732—Repairing by attaching repair preform, e.g., remaking, restoring, or patching
Definitions
- the present disclosure relates generally to remanufactured medical devices and, more particularly, to remanufacturing sensors used for sensing physiological parameters of a patient.
- EEG monitors use non-invasive electrophysiological monitoring to evaluate global changes in a patient's condition, for example, during surgical procedures. Examples of global changes may include assessing the effects of anesthetics, evaluating asymmetric activity between the left and right hemispheres of the brain in order to detect cerebral ischemia, and detecting burst suppression.
- One such technique includes bispectral index (BIS) monitoring to measure the level of consciousness by algorithmic analysis of a patient's EEG during general anesthesia.
- BIOS bispectral index
- EEG measurements are captured using EEG monitoring devices, and sensors associated with these monitoring devices are applied to the patient.
- the sensors include electrodes that may be applied to various anatomies of the patient (e.g., the temple and/or forehead).
- sensors for BIS monitoring may include a single strip that includes several electrodes for placement on the forehead to noninvasively acquire an EEG signal. Because the BIS sensors are placed in direct contact with a patient, and possibly patient fluids, BIS sensors are typically intended for use with a single patient. Thus, BIS sensors are typically discarded after use.
- FIG. 1 is a front view of an embodiment of a monitoring system configured to be used with a sensor for performing BIS measurements, in accordance with an aspect of the present disclosure
- FIG. 2 is an exploded perspective view of an embodiment of the sensor of FIG. 1 , in accordance with an aspect of the present disclosure
- FIG. 3 is a schematic representation of an embodiment of the sensor of FIG. 2 in packaged form, in accordance with an aspect of the present disclosure
- FIG. 4 is a process flow diagram of an embodiment of a general method for remanufacturing the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 5 is a process flow diagram of an embodiment of a method for remanufacturing the sensor of FIGS. 1-3 , including refurbishing the body of the sensor, in accordance with an aspect of the present disclosure
- FIG. 6 is a process flow diagram of an embodiment of a method for removing and replacing features disposed within electrode wells of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 7 is a process flow diagram of an embodiment of a method for removing and replacing features disposed within electrode wells of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 8 is a process flow diagram of an embodiment of a method for removing and replacing features disposed within electrode wells of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 9 is a process flow diagram of an embodiment of a method for removing and replacing features disposed within electrode wells of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 10 is a cross-sectional view, taken along line 10 - 10 , of an embodiment of the sensor of FIGS. 1-3 having a self-supporting conductive gel, in accordance with an aspect of the present disclosure
- FIG. 11 is a process flow diagram of an embodiment of a method for removing features disposed within electrode wells of the sensor of FIGS. 1-3 and replacing the features with the self-supporting conductive gel of FIG. 10 , in accordance with an aspect of the present disclosure;
- FIG. 12 is a process flow diagram of an embodiment of a method for remanufacturing a body of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 13 is a cross-sectional view, taken along line 10 - 10 , of an embodiment of the sensor of FIGS. 1-3 having multiple foam layers, in accordance with an aspect of the present disclosure
- FIG. 14 is a process flow diagram of an embodiment of a method for remanufacturing a body of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 15 is a process flow diagram of an embodiment of a method for remanufacturing a body of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 16 is a cross-sectional view, taken along line 10 - 10 , of an embodiment of the sensor of FIGS. 1-3 having an additional patient-contacting adhesive disposed over a used patient-contacting adhesive, in accordance with an aspect of the present disclosure
- FIG. 17 is a process flow diagram of an embodiment of a method for remanufacturing a body of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 18 is an exploded perspective view of an embodiment of the sensor of FIGS. 1-3 and illustrating a plurality of patient-contacting layers laminated over a foam layer of the sensor, in accordance with an aspect of the present disclosure
- FIG. 19 is a process flow diagram of an embodiment of a method for remanufacturing a body of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 20 is a process flow diagram of an embodiment of a method for remanufacturing the sensor of FIGS. 1-3 including replenishing the conductive ink of the electrodes and/or conductors of the sensor, in accordance with an aspect of the present disclosure
- FIG. 21 is a process flow diagram of an embodiment of a method for replenishing the conductive ink of the electrodes and/or conductors of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 22 is a cross-sectional view, taken along line 10 - 10 , of an embodiment of the sensor of FIGS. 1-3 having a new conductive ink disposed over a used conductive ink, in accordance with an aspect of the present disclosure
- FIG. 23 is a process flow diagram of an embodiment of a method for replenishing the conductive ink of the electrodes and/or conductors of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 24 is a schematic depiction of an embodiment of a process for ionizing a metallic ink disposed on the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 25 is a process flow diagram of an embodiment of a method for replenishing the conductive ink of the electrodes and/or conductors of the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure
- FIG. 26 is a process flow diagram of an embodiment of a method for refurbishing the memory unit of the sensor of FIGS. 1-3 , including replacing the connector of the sensor, in accordance with an aspect of the present disclosure;
- FIG. 27 is a process flow diagram of an embodiment of a method for refurbishing the memory unit of the sensor of FIGS. 1-3 , including re-programming the memory unit contained within the connector of the sensor, in accordance with an aspect of the present disclosure;
- FIG. 28 is a front view of an embodiment of the sensor of FIGS. 1-3 having an adapter coupled to the connector for altering the operability of the memory unit, in accordance with an aspect of the present disclosure
- FIG. 29 is a process flow diagram of an embodiment of a method for refurbishing the memory unit of the sensor of FIGS. 1-3 , including providing an adaptor for the time-out feature contained within the connector of the sensor, in accordance with an aspect of the present disclosure;
- FIG. 30 is a process flow diagram of an embodiment of a method for refurbishing memory unit of the sensor of FIGS. 1-3 , including emulating the memory unit on a new memory unit, in accordance with an aspect of the present disclosure;
- FIG. 31 is a process flow diagram of an embodiment of a method for remanufacturing the sensor of FIGS. 1-3 including retaining only the connector and memory unit and replacing the used sensor with a new sensor, in accordance with an aspect of the present disclosure;
- FIG. 32 is a front view of an embodiment of a sensor having new components and remanufactured components from the sensor of FIGS. 1-3 , in accordance with an aspect of the present disclosure.
- FIG. 33 is a process flow diagram of an embodiment of a method for remanufacturing the sensor of FIGS. 1-3 to produce the sensor of FIG. 32 , in accordance with an aspect of the present disclosure.
- the present disclosure is generally directed to the remanufacturing of bispectral index (BIS) sensors having one or more electrodes for monitoring brain activity of a patient.
- the sensors described herein may include one or more electrodes, such as at least two electrodes, for capturing electrical data from a patient's brain, and features for facilitating the capture and transmittal of the data from the patient to a patient monitor.
- the BIS sensors described herein may be constructed using a combination of new materials (i.e., materials that have not been incorporated into a BIS sensor) and components taken from one or more used BIS sensors (e.g., an electrode).
- a BIS sensor may include a base layer supporting a flexible array of electrodes configured to capture electrical data from a patient, a conductive gel to facilitate the transmission of the electrical signals from the patient to the sensor, one or more foam pieces to pad the BIS sensor, and an adhesive layer for attaching the sensor to the patient, such as to the patient's forehead and/or temple.
- BIS sensors constructed using the remanufacturing techniques described herein may incorporate used foam layers, flexible circuits, and, in certain embodiments, existing but unused adhesive layers, or any combination thereof.
- a BISTM sensor available from Aspect Medical Systems, Inc., such as a BISTM Quattro sensor, a BISTM extend sensor, a BISTM pediatric sensor, or a BISTM bilateral sensor, which include a plurality of printed electrodes on a flexible substrate, represent one type of EEG sensor. It should be noted, however, that the present disclosure is applicable to any EEG or similar sensor having similar or the same materials and/or configuration as those described herein. Further, other sensors having some or all of the components described herein (e.g., ECG sensors, general EEG sensors, pulse oximetry sensors, or sensors used for measuring water fraction or hematocrit) may benefit from the disclosed techniques.
- the BIS sensors disclosed herein may be used in conjunction with any suitable monitoring system, which is described with respect to FIG. 1 .
- An example BIS sensor and its components are discussed with respect to FIG. 2
- a packaged EEG sensor is discussed with respect to FIG. 3 .
- these sensors are generally known to be one-time-use sensors that may be discarded after use by one patient.
- some components of these used sensors such as the conductors, connectors, and memory units associated therewith, may be employed in the construction of remanufactured sensors. Reusing these components to reconstruct a sensor may reduce waste (e.g., plastic waste materials), consequently reducing an impact on the environment, while accordingly reducing costs.
- waste e.g., plastic waste materials
- FIG. 1 is a front view of an embodiment of a patient monitoring system 10 .
- the monitoring system 10 may include a sensor 12 and an EEG monitor 14 .
- the sensor 12 may include electrodes 16 (e.g., four electrodes 16 A, 16 B, 16 C, and 16 D) that may be self adherent and self prepping to temple and forehead areas of a patient and that are used to acquire EEG signals.
- the electrodes 16 may include a printed conductive ink supported within a flexible sensor body 18 to provide enhanced flexibility and conformance to patient tissue.
- the sensor 12 may include a paddle connector 20 , which couples through a connector 22 to a cable 24 (e.g., a patient interface cable), which in turn may be coupled to a cable 26 (e.g., a pigtail cable). In certain embodiments, the sensor 12 may be coupled to the cable 26 thereby eliminating the cable 24 .
- the cable 26 may be coupled to a digital signal converter 28 , which in turn is coupled to the cable 30 (e.g., a monitor interface cable). In certain embodiments, the digital signal converter 28 may be embedded in the monitor 14 to eliminate the cables 26 and 30 . Cable 26 may be coupled to the monitor 14 via a port 32 (e.g., a digital signal converter port).
- the monitor 14 may be capable of calculating physiological characteristics relating to the EEG signal received from the sensor 12 .
- the monitor may be capable of algorithmically calculating BIS from the EEG signal.
- BIS is a measure of a patient's level of consciousness during general anesthesia.
- the monitor 14 may include a display 34 capable of displaying physiological characteristics, historical trends of physiological characteristics, other information about the system (e.g., instructions for placement of the sensor 12 on the patient), and/or alarm indications.
- the monitor 14 may display a patient's BIS value 36 .
- the BIS value 36 represents a dimensionless number (e.g., ranging from 0, i.e., silence, to 100, i.e., fully awake and alert) output from a multivariate discriminate analysis that quantifies the overall bispectral properties (e.g., frequency, power, and phase) of the EEG signal.
- a BIS value 36 between 40 and 60 may indicate an appropriate level for general anesthesia.
- the monitor 14 may also display a signal quality index (SQI) bar graph 38 (e.g., ranging from 0 to 100) which measures the signal quality of the EEG channel source(s) based on impedance data, artifacts, and other variables.
- SQL signal quality index
- the monitor 14 may yet also display an electromyograph (EMG) bar graph 40 (e.g., ranging from 30 to 55 decibels) which indicates the power (e.g., in decibels) in the frequency range of 70 to 110 Hz.
- the frequency range may include power from muscle activity and other high-frequency artifacts.
- the monitor 14 may further display a suppression ratio (SR) 42 (e.g., ranging from 0 to 100 percent), which represents the percentage of epochs over a given time period (e.g., the past 63 seconds) in which the EEG signal is considered suppressed (i.e., low activity).
- EEG electromyograph
- SR suppression ratio
- the monitor 14 may also display a burst count for the number of EEG bursts per minute, where a “burst” is defined as a short period of EEG activity preceded and followed by periods of inactivity or suppression.
- the monitor 14 may yet further display the EEG waveform 44 .
- the EEG waveform 42 may be filtered.
- the monitor 14 may still further display trends 46 over a certain time period (e.g., one hour) for EEG, SR, EMG, SQL and/or other parameters.
- the monitor 14 may display stepwise instructions for placing the sensor 12 on the patient.
- the monitor 14 may display a verification screen verifying the proper placement of each electrode 16 of the sensor 12 on the patient.
- the monitor 14 may store instructions on a memory specific to a specific sensor type or model, which is discussed in further detail below.
- the sensor 12 may include a memory that provides the instructions to the monitor 14 .
- the monitor 14 may include various activation mechanisms 48 (e.g., buttons and switches) to facilitate management and operation of the monitor 14 .
- the monitor 14 may include function keys (e.g., keys with varying functions), a power switch, adjustment buttons, an alarm silence button, and so forth.
- the parameters described above and the activation mechanisms 48 may be arranged on different parts of the monitor 14 .
- the parameters and activation mechanisms 48 need not be located on a front panel 50 of the monitor 14 .
- activation mechanisms 48 are virtual representations in a display or actual components disposed on separate devices.
- the activation mechanisms 48 may allow selecting or inputting of a specific sensor type or model in order to access instructions stored within the memory of the sensor 12 .
- FIG. 2 may generally represent the BISTM Quattro sensor, the BISTM extend sensor, the BISTM pediatric sensor, or the BISTM bilateral sensor mentioned above.
- the embodiment of the sensor 12 illustrated in FIG. 2 may represent a BISTM Quattro sensor, wherein electrode 16 A is configured to function as a sensing electrode, electrode 16 B is configured to monitor artifacts resulting from muscular movement, such as eye twitching, electrode 16 C is configured to function as a grounding electrode, and electrode 16 D is configured to function as a reference electrode.
- the sensor 12 may be capable of performing BIS measurements with fewer than four electrodes 16 , or more than four electrodes 16 .
- the sensor 12 may be capable of performing BIS measurements using only electrodes 16 A, 16 C, and 16 D.
- the electrodes 16 may include a reference electrode configured to be placed at the center of the patient's forehead, two electrodes each configured to be placed above an eye of the patient to monitor artifacts from eye twitching or movement, one ground electrode, and two electrodes each configured to be placed against the patient's temples for monitoring.
- the sensor 12 includes a base structural layer 60 , a foam layer 62 , a first adhesive 64 configured to secure the foam layer 62 to the base structural layer 60 , and a patient-contacting adhesive 66 configured to secure the sensor 12 to a patient.
- the base structural layer 60 may be constructed from any flexible polymeric material suitable for use in medical devices, such as polyester, polyurethane, polypropylene, polyethylene, polyvinylchloride, acrylics, nitrile, PVC films, acetates, or similar materials that facilitate conformance of the sensor 12 to the patient.
- the foam layer 62 may be relatively rigid compared to the base structural layer 60 to provide padding and additional comfort to the patient.
- the foam layer 62 may include any foam material suitable for use in medical applications, such as polyester foam, polyethylene foam, polyurethane foam, or the like.
- the first adhesive 64 and the patient-contacting adhesive 66 may include pressure sensitive adhesives such as an acrylic-based adhesive, a supported transfer tape, an unsupported transfer tape, or any combination thereof.
- the patient-contacting adhesive 66 may include a hydrocolloid or similar adhesive for patients with sensitive skin. It should be noted that the foam layer 62 and adhesives 64 , 66 may be provided as discrete layers as illustrated, or may be provided as a single piece. That is, the foam layer 62 and the adhesives 64 , 66 may be provided as a double-coated foam layer.
- the foam layer 62 and the adhesives 64 , 66 may also include respective tabs 63 , 65 , 67 to facilitate removal of each layer 62 , 64 , 66 during remanufacture.
- the base structural and foam layers 60 , 62 and adhesives 64 , 66 form the sensor body 18 , which is the structural support in which the features for collecting EEG-related data from the patient are disposed.
- the sensor body 18 may be configured to facilitate proper placement of the sensor 12 on a patient's head.
- the sensor body 18 may include a first body portion 68 and a second body portion 70 that are joined by a thin bridge 72 of the base structural layer 60 , and are separated by a discontinuation 74 in the foam layer 62 and adhesives 64 , 66 .
- the base structural layer 60 may be constructed from a flexible polymeric material, the bridge 72 is able to bend with a relatively high degree of freedom (e.g., compared to the foam layer 62 ).
- the electrodes 16 B, 16 C, and 16 D which are located on the first body portion 68 , may be placed on a patient's forehead, while electrode 16 A, which is located on the second body portion 70 , is placed on the patient's temple. Therefore, because the bridge 72 can easily bend, the sensor 12 is able to accommodate a variety of distances between the forehead and temple areas (i.e., head sizes) by enabling the sensor 12 to arch, twist, or flex between the first and second body portions 68 , 70 .
- the illustrated placement of the bridge 72 is only one embodiment, and that the bridge 72 may be placed between other electrodes 16 in other configurations.
- the bridge 72 may be between the electrode 16 B and the electrode 16 C rather than the illustrated placement.
- the sensor 12 may include more than one bridge 72 , such as two or more bridges 72 disposed between the electrodes 16 (e.g., in a BISTM bilateral sensor).
- a length l 1 of the bridge 72 may be varied depending on the end use of the sensor 12 (e.g., pediatric, small, regular, or large sizes).
- the senor 12 may not include a bridge portion and may include configurations similar to those described in U.S. patent application Ser. No. 13/074,127 entitled “Method and System for Positioning a Sensor,” filed Mar. 28, 2011, which is incorporated by reference herein in its entirety for all purposes.
- the base structural layer 60 of the sensor 12 also includes a plurality of electrode portions 76 each having a particular shape.
- the shape of the electrode portions 76 may be configured to facilitate retention of the sensor 12 on the patient, and, more specifically, to maintain pressure of the corresponding electrode 16 on the electrode portion 76 against the patient's forehead or temple. As illustrated, the electrodes 16 are generally positioned at the center of their respective electrode portion 76 .
- the shapes of the electrode portions 76 may also be reflected in the shape of the foam layer 62 and the adhesives 64 , 66 , and, more specifically, the portions of the foam layer 62 and the adhesives 64 , 66 that may attach to corresponding electrode portions 76 of the base structural layer 60 .
- the foam layer 62 and the adhesives 64 , 66 also include respective holes 78 , 80 , 82 corresponding to the position of the electrodes 16 to facilitate electrical contact with the patient.
- the electrodes 16 are constructed from conductive materials to enable the sensor 12 to perform electrical measurements on the patient.
- the electrodes 16 are formed from flexible conductive materials, such as one or more conductive inks.
- the electrodes 16 may be produced by printing (e.g., screen printing or flexographic printing) a conductive ink on the base structural layer 60 and allowing the ink to dry and/or cure.
- the ink may be thermally cured.
- the sensor 12 may also include a plurality of conductors 84 disposed (e.g., screen or flexographically printed) on the base structural layer 60 to transmit signals to and from each of the electrodes 16 and to enhance flexibility of the sensor 12 .
- the conductors 84 may be formed from the same or a different conductive ink than the electrodes 16 .
- Suitable conductive inks for the electrodes 16 and the conductors 84 may include inks having one or more conductive materials such as metals (e.g., copper (Cu) or silver (Ag)) and/or metal ions (e.g., silver chloride (AgCl)), filler-impregnated polymers (e.g., polymers mixed with conductive fillers such as graphene, conductive nanotubes, metal particles), or any ink having a conductive material capable of providing conductivity at levels suitable for performing the EEG or other electrical measurements.
- metals e.g., copper (Cu) or silver (Ag)
- metal ions e.g., silver chloride (AgCl)
- filler-impregnated polymers e.g., polymers mixed with conductive fillers such as graphene, conductive nanotubes, metal particles
- any ink having
- the electrodes 16 and/or conductors 84 may be formed from an ink having a mixture of Ag and AgCl.
- silver and salts thereof e.g., Ag/AgCl
- the Ag/AgCl may enable the sensor to depolarize within a desired amount of time (e.g., seconds rather than minutes). This depolarization within a short amount of time may enable the sensor 12 to be used a short time after the defibrillation or similar procedure.
- any suitable conductive material may be used for the electrodes 16 and the conductors 84 .
- the conductors 84 are generally configured to transmit signals to and/or from the electrodes 16 .
- the conductors 84 may be configured transmit signals such as power, data, and the like, collected at or transmitted to each of the electrodes 16 to or from a tail portion 86 of the base structural layer 60 .
- the tail portion 86 of the base structural layer 60 includes an interface region 88 in which the sensor 12 is configured to couple to another connector or the monitor 14 to enable the monitor 14 to perform BIS measurements.
- the tail portion 86 may be a flat, flexible protrusion from the body portion 18 of the sensor 12 to enable the sensor 12 to be worn by the patient with minimal discomfort by reducing the bulk and weight of the sensor 12 on the patient.
- the tail portion 86 and the paddle connector 20 interface with one another at respective overlapping connection regions 90 , 92 .
- This enables the sensor 12 to physically couple to the connector 22 or the monitor 14 of FIG. 1 .
- the paddle connector 20 may be configured to enable the sensor 12 to clip into the connector 22 and/or the monitor 14 .
- the paddle connector 20 may also include a memory unit 94 configured to store information relating to the sensor 12 , and to provide the stored information to the monitor 14 .
- the memory unit 94 may store code configured to provide an indication to the monitor 14 as to the make/model of the sensor 12 , the time-in-operation of the sensor 12 , the number of times the sensor 12 has been remanufactured, or the like.
- the memory unit 94 may include code configured to perform a time-out function where the sensor 12 is deactivated after a predetermined number of connections, time-in-operation, or similar use-related metric.
- the memory unit 94 may also store patient-specific and/or sensor-specific information such as trend data collected by the electrodes 16 , calibration data related to the electrodes 16 and/or conductors 84 , and so on.
- the memory unit 94 may be configured to enable the sensor 12 to be used in conjunction with the monitor 14 for the collection of patient data.
- the sensor 12 may be kept in electrical contact with the patient for the collection of EEG or similar data. Accordingly, the sensor 12 may also include a conductive gel 96 configured to conduct electrical signals between the electrodes 16 and the patient tissue.
- the conductive gel 96 may include a wet gel or a hydrogel that is compatible with the materials used for the electrodes 16 and the conductors 84 .
- the conductive gel 96 may include a salt (e.g., sodium chloride (NaCl) or potassium chloride (KCl)) having an ionic concentration suitable for conducting electrical signals between the patient and the electrodes 16 .
- the concentration of chloride ions in the conductive gel 96 may be between approximately 2 and 10% by weight.
- the conductive gel 96 may be disposed within electrode wells (e.g., FIG. 10 ) corresponding to each of the electrodes 16 and defined by the base structural layer 60 , the foam layer 62 , and the holes 78 . As illustrated, the conductive gel 96 may be applied by a tube or packet 98 over the corresponding position of the electrodes 16 . However, as discussed below, in some embodiments the conductive gel 96 may be provided as a bubble of gel that is disposed in each electrode well and is configured to burst when applied to the patient. Further, in certain embodiments, the conductive gel 96 may have a viscosity that enables the conductive gel 96 to be self-supporting.
- the conductive gel 96 may be the only material disposed within the electrode wells. However, in the illustrated embodiment, the conductive gel 96 may have a viscosity such that the conductive gel 96 may not remain within the electrode wells before the sensor 12 is applied to the patient. Accordingly, the sensor 12 may also include a series of gel support structures 100 that are configured to support the conductive gel 96 in the sensor 12 (i.e., within each electrode well). In accordance with an embodiment, the gel support structures 100 may include an open cell foam sponge material configured to hold the conductive gel 96 within the wells.
- the gel support structures 100 may each be disposed over respective preparation surfaces 102 , each of which include a series of protrusions 103 .
- the preparation surfaces 102 may include a plastic material, such as a plastic backing and associated set of protrusions produced by modification (e.g., shaving) of a hook portion of a hook and loop fastener.
- the protrusions 103 of the preparation surfaces 102 may prepare the patient for monitoring by penetrating the interface between the patient's skin and the electrodes 16 .
- the sensor 12 may be considered to be a self-prepping sensor.
- the preparation surfaces 102 may be secured to the electrodes 16 by adhesive foam dots 104 .
- the gel support structures 100 , the preparation surfaces 102 , and the adhesive foam dots 104 may be referred to as electrode well structures 106 .
- the adhesive foam dots 104 which may be formed from the same or a different foam material than the foam layer 62 , attach directly to the electrodes 16 .
- the adhesive foam dots 104 will have a cylindrical shape, though they may be any suitable shape and size.
- the adhesive foam dots 104 may have a surface area at each axial extent that is smaller than a surface area of each electrode 16 such that a sufficient portion of the electrodes 16 are left uncovered to ensure suitable conductance between the electrodes 16 and the patient.
- the adhesive foam dots 104 may be double-coated with adhesive, as illustrated, or may have discrete adhesive layers attached at each axial extent, as illustrated in FIG. 13 .
- the gel support structures 100 may be sized so as to be substantially flush with, or stand slightly proud of, the sensor body 18 .
- FIG. 3 depicts an embodiment of the manner in which the sensor 12 may be packaged.
- the sensor 12 is placed on a liner 110 , which may include a series of indentations 112 for receiving each of the gel support structures 100 .
- the liner 110 may include any suitable lining material that is appropriate for use in conjunction with the materials of the sensor 12 and the conductive gel 96 .
- the liner 110 may include a siloxane material, a polyethylene liner material, a polystyrene liner material, a polyester liner material, or the like.
- the sensor 12 and liner 110 are contained within a packaging 114 .
- the packaging 114 may include a packaging material suitable for retaining the moisture of the conductive gel 96 when the sensor 12 is stored. That is, the packaging 114 may prevent the conductive gel 96 of the sensor 12 from drying out, which could prevent the sensor 12 from having a suitable level of electrical conductivity with the patient. Accordingly, the packaging 114 will generally have a moisture vapor transmission rate (MVTR) that is sufficiently low to prevent the conductive gel 96 from drying.
- the packaging 114 may include metal barrier materials such as an aluminum foil material, polymeric barrier materials such as biaxially oriented polyethylene terephthalate (BoPET), a metalized barrier film (e.g., metalized PET), or any combination thereof.
- FIG. 4 illustrates a generalized sensor remanufacturing method
- FIGS. 5-27 illustrate sensor remanufacturing methods for replacing and/or refurbishing various features of the sensor 12
- FIGS. 28-33 each illustrate a connector/memory unit remanufacturing method that can be performed in conjunction with or independently of the methods of FIGS. 5-27 .
- a method 120 for remanufacturing a medical sensor such as the sensor 12
- the method begins with obtaining a used version of the sensor 12 (block 122 ).
- the used version of the sensor 12 may be a single-use medical sensor (i.e., for use on a single patient) or may be a reusable sensor.
- the sensor 12 may be obtained, as an example, by a technician or similar manufacturing personnel.
- the sensor 12 may be sterilized before or after the acts represented by block 122 such that the sensor 12 is suitable for handling by a technician or similar worker.
- the sensor 12 may also undergo inspection and/or testing to determine the operability of the sensor 12 (block 124 ).
- the testing may include testing the operation and accuracy of the electrodes 16 , the paddle connector 20 , the sensor cable 24 , and any other electronic features of the sensor 12 , such as the memory unit 94 .
- the sensor 12 After the sensor 12 has been inspected and tested, it may be determined whether it is appropriate to remanufacture the sensor (query 126 ). For example, it may be determined whether the sensor 12 includes suitable components for remanufacture (e.g., by reviewing the results of the sensor testing acts of block 124 and/or visual inspection). Alternatively or additionally, it may be determined whether the sensor 12 has undergone previous iterations of remanufacturing. Accordingly, the sensor 12 may include one or more indications as to whether the sensor 12 has been previously remanufactured, such an external mark on the sensor 12 or a counter stored on the memory unit 94 .
- the memory unit 94 may track the number of times the sensor 12 has undergone sterilization procedures (e.g., ethylene oxide (EtO) gas, gamma irradiation, autoclaving, chemical sanitation, Pasteurization), memory clearing, memory re-programming, and the like.
- sterilization procedures e.g., ethylene oxide (EtO) gas, gamma irradiation, autoclaving, chemical sanitation, Pasteurization), memory clearing, memory re-programming, and the like.
- the used version of the sensor 12 may be discarded (block 128 ).
- one or more features of the used version of the sensor 12 may be inoperative, such as the paddle connector 20 , the cable 24 , and so on.
- the sensor 12 may have an external mark or a stored counter that indicates that the sensor 12 is not suitable for remanufacture. Indeed, as discussed herein, the external markings and/or the counter on the memory unit 94 may be incremented with each remanufacturing procedure.
- the senor 12 may be remanufactured according to certain remanufacturing processes (block 130 ).
- the sensor 12 may be remanufactured according to certain remanufacturing processes.
- the sensor 12 may be remanufactured. Embodiments of certain remanufacturing processes are discussed below.
- the sensor 12 is then tested to ensure that it is within certain operational tolerances (block 132 ).
- the sensor 12 may be attached or otherwise coupled to a test rig, which may determine and, if suitable, adjust varying operational parameters of the sensor 12 .
- various sensor-specific information may be stored on the memory unit 94 , such as conductance-related data if the electrodes 16 and/or conductors 84 are refurbished, information pertaining to the sensor 12 (e.g., the name of the sensor 12 , a model code for the sensor 12 ), or the like.
- the sensor 12 may then be packaged (block 134 ) and sent to a medical facility for use.
- FIG. 5 illustrates an embodiment of a method 140 for remanufacturing the sensor 12 that includes refurbishing portions of the sensor body 18 and the memory unit 94 .
- the method 130 may include obtaining a used version of the sensor 12 (block 122 ), which may generally correspond to the acts described above with respect to FIG. 4 .
- the senor 12 may be obtained directly from a medical facility or from a third party that may obtain the sensor 12 directly or indirectly from a medical facility. Once the sensor 12 is obtained, the sensor 12 may be prepared for remanufacturing (block 124 ) by sterilization or other preparation steps, as discussed above with respect to FIG. 4 .
- the gel support structures 100 , the preparation surfaces 102 , the adhesive foam dots 104 , or any combination thereof may be removed from the electrode wells to expose the electrodes 16 .
- the gel support structures 100 and the preparation surfaces 102 may be removed from the adhesive foam dots 104 such that only a portion of the electrodes 16 are exposed.
- the conductive gel 96 may be removed from the sensor 12 (block 144 ).
- the conductive gel 96 may be removed from the sensor 12 using an aqueous solution (e.g., water, deionized water, or water with a surfactant) to dissolve the conductive gel 96 , compressed air to blow the conductive gel 96 out, the conductive gel 96 may simply be wiped out using a cloth or the like, or any combination thereof.
- an aqueous solution e.g., water, deionized water, or water with a surfactant
- the conductive gel 96 may be removed using chemical solutions other than aqueous solutions (e.g., organic-based solutions), though it should be noted that it may be desirable to avoid solvents that may undesirably dissolve the base support layer 60 and/or the foam layer 62 . Further, in embodiments where a solution is used to remove the conductive gel 96 , a drying step may also be performed to remove any remaining liquid from the sensor 12 .
- aqueous solutions e.g., organic-based solutions
- a drying step may also be performed to remove any remaining liquid from the sensor 12 .
- the foam layer 62 and the adhesive layers 64 , 66 may be refurbished (block 146 ) according to certain protocols, examples of which are described in detail below with respect to FIGS. 13-20 .
- the foam layers and adhesive layers 64 , 66 have been refurbished, the features that have been removed in accordance with block 142 may be replaced.
- Embodiments of the manner in which the portion of the support structures 100 are removed in accordance with block 142 and replaced in accordance with block 148 are discussed in further detail below with respect to FIGS. 6-12 .
- the conductive gel 96 is provided (block 150 ).
- the acts represented by block 150 may include disposing the conductive gel 96 over the electrodes 16 , or providing the conductive gel 96 in a separate dispenser so as to allow a caregiver (e.g., a clinician, nurse, doctor) to dispose the conductive gel 96 in the sensor 12 just before use.
- the conductive gel 96 may have a viscosity sufficient so as to allow the sensor 12 to be used without the gel support structures 100 .
- the memory unit 94 may also be refurbished (block 152 ). For example, the memory unit 94 may be cleared, re-programmed, replaced, or the like. Embodiments relating to refurbishing the memory unit 94 , such as by replacing or re-programming the memory unit 94 , are discussed in further detail below with respect to FIGS. 27-32 .
- the sensor 12 Before, during, or after refurbishing the memory unit 94 , the sensor 12 may be placed on the liner 110 (block 154 ). For example, in embodiments where the conductive gel 96 is disposed in the sensor 12 , the sensor 12 may be placed on the liner 110 shortly after disposing the conductive gel 96 in the sensor 12 to help retain the conductive gel 96 .
- the gel support structures 100 , the preparation surfaces 102 , the adhesive foam dots 104 , or any combination thereof, may be removed and/or replaced during remanufacture of the sensor 12 .
- One embodiment of a method 160 for refurbishing the electrode well supporting structures 100 is illustrated in FIG. 6 .
- the method 160 may include removing the preparation surfaces 102 and the adhesive foam dots 104 from the electrodes 16 (block 162 ).
- the preparation surfaces 102 may be removed from the adhesive foam dots 104
- the adhesive foam dots 104 may be removed from the sensor 12 by shaving, peeling, or pulling the adhesive foam dots 104 away from the electrodes 16 . Because the adhesive foam dot 104 may be damaged or otherwise unsuitable for use in the remanufactured sensor 12 , a new adhesive foam dot 104 may be provided (block 164 ).
- the gel support structures 100 and the preparation surfaces 102 may be removed from the sensor 12 before the conductive gel 96 is removed (e.g., in block 144 of FIG. 5 ). Accordingly, the conductive gel 96 may also be removed from the gel support structures 100 and the preparation surfaces 102 (block 166 ). For example, as discussed above with respect to block 144 of FIG. 5 , the conductive gel 96 may be removed by washing with water, soapy water, another aqueous solution, an organic chemical solution, by wiping, by blowing with compressed air, or any combination thereof.
- the conductive gel 96 trapped within the electrode well support structures 100 and/or the preparation surfaces 102 may contain debris from a previous use, the either or both may be separately sanitized using EtO gas, autoclaving, Pasteurization, gamma irradiation, or any other suitable sterilization technique known in the art.
- EtO gas EtO gas
- the gel support structures 100 , the preparation surfaces 102 , and the new adhesive foam dots 104 may then be disposed on the electrodes 16 (block 168 ).
- FIG. 7 illustrates an embodiment of a method 170 in which the used adhesive foam dots 104 are retained within the sensor 12 .
- the method 170 includes removing the gel support structures 100 and the preparation surfaces 102 while leaving the adhesive foam dots 104 attached to the electrodes 16 (block 172 ).
- the conductive gel 96 may then be removed from the gel support structures 100 and the preparation surfaces 102 in accordance with block 166 described above.
- the cleaned gel support structures 100 and the preparation surfaces 102 may then be re-adhered to the adhesive foam dots 104 (block 174 ).
- FIG. 8 illustrates an embodiment of one such method 180 for replacing the electrode well structures 106 .
- the method 180 includes removing the electrode well structures 106 from the electrodes 16 (block 162 ), as discussed above with respect to FIG. 6 .
- New electrode well structures 106 may be provided (block 182 ). It should be noted that the new electrode well structures 106 may be the same or different than the used versions, depending on cost of replacement or other considerations, such as new or improved materials, or the like.
- the new electrode well structures 106 may then be adhered to the electrodes 16 (block 184 ).
- FIG. 9 illustrates one embodiment of such a method 190 .
- the method 190 includes removing the gel support structures 100 and the preparation surfaces 102 from the adhesive foam dots 104 (block 172 ) as described above with respect to FIG. 7 .
- New gel support structures 100 and the preparation surfaces 102 may be provided (block 192 ), which may be the same or different than the used gel support structures 100 and the preparation surfaces 102 .
- the new gel support structures 100 and the preparation surfaces 102 may then be adhered to the adhesive foam dots 104 (block 194 ).
- the electrode well structures 106 are generally configured to support the conductive gel 96 within the sensor 12 so as to retain the conductive gel 96 within the sensor 12 , and also to prepare the patient for monitoring as the sensor 12 is attached to the patient's forehead and temple (or other somatic region).
- the conductive gel 96 may have a sufficient viscosity so as to preclude the use of the gel support structures 100 .
- FIG. 10 is a cross-section of the sensor 12 taken along line 10 - 10 , and illustrates one such embodiment where the conductive gel 96 is self-supporting within an electrode well 200 of the sensor 12 .
- the sensor 12 does not include the gel support structures 100 .
- the sensor 12 may include the adhesive foam dot 104 and the preparation surface 102 .
- FIG. 10 also illustrates the self-supporting conductive gel 96 as in direct contact with the electrodes 16 , which may be coextensive with the conductors 84 . As illustrated, the conductors 84 are disposed underneath the foam layer 62 while the electrodes 16 are exposed.
- An embodiment of a method 210 for producing the embodiment of the sensor 12 of FIG. 10 from the embodiment of the sensor 12 of FIG. 2 is illustrated in FIG. 11 .
- the method 210 includes removing the electrode well structures 106 from the electrode wells 200 (block 162 ), as discussed above with respect to FIG. 6 .
- a new conductive gel 96 may be provided (block 212 ).
- the new conductive gel 96 may have a viscosity that is the same, or greater than the conductive gel 96 used in the used sensor 12 .
- the conductive gel 96 may have a higher viscosity by having a lower concentration of water or other fluid, by having a polymer with a greater molecular weight, by having a polymer with a lower solubility, or the like.
- the viscous conductive gel 96 may then be disposed in the electrode wells 200 (block 214 ) in place of the electrode well structures 106 .
- FIGS. 12-19 depict embodiments of methods for refurbishing these layers, and the resulting configurations of the sensor 12 .
- FIGS. 12 , 14 , 15 , 17 , and 18 each illustrate an embodiment of the acts represented by block 146 of FIG. 5 .
- FIG. 12 illustrates an embodiment of a method 146 A that includes replacing the foam layer 62 and adhesives 64 , 66 .
- the method 146 A may begin by removing the existing foam layer 62 and associated adhesives 64 , 66 away from the base structural layer 60 of the sensor 12 (block 220 ).
- the sensor 12 may be warmed to reduce the adhesive bond strength of the first adhesive layers 64 to facilitate separation of the foam layer 62 away from the base structural layer 60 .
- the foam layer 62 and adhesives 64 , 66 may be shaved or otherwise cut away from the base structural layer 60 .
- the adhesives 64 , 66 may be dissolved using a solvent to facilitate removal of the foam layer 62 .
- the solvent may be selected so as to dissolve the adhesives 64 , 66 without dissolving the foam layer 62 or base structural layer 60 .
- the foam layer 62 and associated adhesives 64 , 66 may be dissolved away from the base structural layer 60 .
- a new foam layer 62 and adhesives 64 , 66 may be provided (block 222 ).
- the new foam layer 62 may include the same or different materials compared to the used foam layer 62
- the adhesives 64 , 66 may be the same or different than the used adhesives 64 , 66 .
- the new first adhesive 64 disposed between the foam layer 62 and the base structural layer 60 may be selected so as to facilitate removal of the foam layer 62 from the base structural layer 60 , for example to facilitate future remanufacturing processes. That is, the new version of the first adhesive 64 may have a lower adhesive bond strength compared to the used version of the first adhesive 64 .
- the material used for the new version of the first adhesive 64 may have a reduced bonding strength compared to the used version.
- the new version of the first adhesive 64 may cover a smaller surface area of the foam layer 62 such that the overall bond of the foam layer 62 to the base structural layer 60 is weaker compared to the used version of the sensor 12 .
- the new foam layer 62 and adhesives 64 , 66 are then adhered to the base structural layer 60 of the sensor 12 (block 224 ).
- FIG. 13 is a cross-sectional view of an embodiment of the sensor 12 after removing a top portion (i.e., closer to the patient-contacting side) of the foam layer 62 and disposing an additional foam layer 230 over the used foam layer 62 .
- a thickness t 1 of the foam layer 62 may be reduced such the sensor 12 may have an optimal overall thickness.
- the illustrated sensor 12 also includes a new adhesive 232 configured to adhere the additional foam layer 230 to the used foam layer 62 , and a patient-contacting adhesive 234 disposed on the additional foam layer 230 configured to adhere the sensor 12 to the patient.
- the additional foam layer 230 may include the same foam material as the used foam layer 62 , may include different foam materials than the used foam layer 62 , or a combination.
- the adhesives 232 , 234 may be the same or different compared to the adhesives 64 , 66 .
- FIG. 13 also provides a cross-sectional view of the adhesive foam dot 104 disposed between first and second adhesives 236 , 238 , which may be coated or layered on the adhesive foam dot 104 .
- the first adhesive 236 is configured to adhere the adhesive foam dot 104 to the electrode 16
- the second adhesive 238 is configured to adhere the adhesive foam dot 104 to a plastic backing 240 of the preparation surface 102 .
- FIG. 14 An embodiment of a method 146 B for producing the sensor 12 of FIG. 13 is illustrated in FIG. 14 .
- the method 146 B includes removing a portion of the foam layer 62 (block 250 ), which may involve shaving, peeling, dissolving, etching, or otherwise separating a first portion of the foam layer 62 away from a second portion of the foam layer 62 . It will be appreciated that in removing the portion of the foam layer 62 that the patient-contacting adhesive 66 is removed as well.
- the additional foam layer 230 and the adhesives 232 , 234 may be provided (block 252 ) and adhered to the remaining portion of the used foam layer 62 (block 254 ).
- FIG. 15 illustrates an embodiment of such a method 146 C in which the adhesive 66 is replaced.
- the method 146 C includes removing the patient-contacting adhesive 66 from the foam layer 62 (block 260 ).
- the patient-contacting adhesive 66 may be removed by pulling on the tab 67 such that the patient-contacting adhesive 66 separates from the foam layer 62 .
- the patient-contacting adhesive 66 may be scraped off, dissolved away, wiped off, or removed by any other suitable adhesive removal technique.
- a new patient-contacting adhesive 66 may be provided (block 262 ).
- the new patient-contacting adhesive 66 may be the same or different adhesive than the used patient-contacting adhesive 66 , and may include an acrylic adhesive, a supported transfer tape, an unsupported transfer tape, or other suitable adhesive material.
- the patient-contacting adhesive 66 may then be adhered to the existing foam layer 62 (block 264 ).
- the new patient-contacting adhesive 266 may be the same or different than the used patient-contacting adhesive 66 , and may be a supported or unsupported transfer tape, an adhesive coating, or any adhesive capable of attaching the sensor 12 to the patient.
- An embodiment of a method 146 D for producing the sensor 12 of FIG. 16 is illustrated in FIG. 17 .
- the method 146 D includes providing the new adhesive 266 (block 270 ), which may be a supported or an unsupported transfer tape layer, or an adhesive coating, as noted above.
- the new patient-contacting adhesive 266 may then be adhered to the used patient-contacting adhesive 66 (block 272 ), which may include laminating the new patient-contacting adhesive 266 on the used patient-contacting adhesive 66 or coating the new patient-contacting adhesive 266 on the used patient-contacting adhesive 66 .
- FIG. 18 it may be desirable to provide a plurality of adhesive layers 280 disposed over the foam layer 62 , as illustrated in FIG. 18 .
- the plurality of adhesive layers 280 are positioned over the first electrode portion 76 A of the sensor 12 , though it should be noted that FIG. 18 is generally representative of multiple adhesive layers 280 positioned over the entire sensor body 18 .
- one adhesive layer 280 may be removed after each patient use. For example, after a patient is monitored using the sensor 12 , one of the adhesive layers 280 may be removed (e.g., during remanufacture) to expose a new adhesive layer 280 .
- the number of adhesive layers 280 may be such that after the adhesive layers 280 are exhausted, the sensor 12 may no longer be suitable for remanufacture.
- the adhesive layers 280 may also each include a tab 282 to facilitate removal during remanufacture.
- the adhesive layers 280 may enable the sensor 12 to be used on a single patient over several uses.
- the adhesive layers 280 may include any adhesive material suitable for use in medical devices, such as acrylic-based adhesives, transfer tape adhesives, or the like.
- FIG. 19 One embodiment of a method 146 E for producing the sensor 12 of FIG. 18 is illustrated in FIG. 19 .
- the method 146 E includes removing the used patient-contacting adhesive layer 66 from the foam layer 62 (block 260 ), as discussed above with respect to FIG. 15 .
- the used patient-contacting adhesive layer 66 may be pulled, shaved, dissolved, or otherwise separated from the foam layer 62 . It should be noted, however, that in some embodiments the used patient-contacting adhesive 66 may be retained.
- the plurality of new adhesive layers 266 may be provided (block 290 ) and adhered to the existing foam layer 62 of the sensor 12 (block 292 ).
- the electrodes 16 and conductors 84 may include a conductive ink composition having a mixture of a conductive metal and metal ion, such as an Ag/AgCl mixture. Accordingly, refurbishing the electrodes 16 and conductors 84 may include re-printing, re-ionizing, or otherwise replenishing the conductive ink.
- the shelf life of the sensors 12 described herein may be greatly reduced when refurbishment of the electrodes 16 and/or conductors 84 is not performed.
- the electrodes 16 and conductors 84 may have poor conductivity, a lack of impedance, or similar diminished electrical properties such that the sensor 12 may not be suitable for performing BIS measurements after a certain amount of time.
- the electrodes 16 and conductors 84 include a conductive ink as described above, it may generally be desirable to replenish the conductive ink during remanufacture of the sensor 12 .
- FIG. 20 an embodiment of a general method 300 for remanufacturing the sensor 12 that includes remanufacturing the electrodes 16 and/or conductors 84 is illustrated in FIG. 20 .
- the method 300 includes several steps that are the same as those described above with respect to FIG. 5 . Accordingly, those steps are discussed using the same reference numerals as used in FIG. 5 .
- the method 300 includes the same acts represented by blocks 122 , 124 , 142 , 144 , 146 , 148 , 150 , 152 , and 154 as described above with respect to FIG. 5 .
- the used version of the sensor 12 may be obtained (block 122 ), which may include obtaining the sensor 12 directly from a medical facility or from a third party that obtains the medical sensor, as discussed above.
- the sensor 12 may be prepared for the remanufacturing process (block 124 ), for example by sterilizing the sensor 12 , removing debris from the previously monitored patient, performing testing on the sensor 12 , or any combination thereof.
- At least a portion of the electrodes 16 may be exposed (block 142 ), for example by removing at least a portion of the electrode well structures 106 .
- the conductive gel 96 may also be removed from the electrode wells 200 (block 144 ) by wiping, dissolution, blowing, or any combination thereof, as discussed above.
- the adhesives 64 , 66 and the foam layer 62 may also be refurbished (block 146 ), for example using the methods described above with respect to FIGS. 12 , 14 , 15 , 17 , and 19 .
- the method 300 also includes, as noted, refurbishing the electrodes 16 and/or the conductors 84 (block 302 ).
- the electrodes 16 and/or conductors 84 may be refurbished by re-printing the conductive ink of the electrodes 16 and/or conductors 84 , re-ionization of the conductive ink of the electrodes 16 and/or conductors 84 or printing a metallic ink and ionizing the metallic ink to produce the electrodes 16 and/or conductors 84 .
- the conductive gel 96 may be provided (block 150 ), as discussed above.
- the memory unit 94 may also be refurbished (block 152 ), and the sensor 12 may be disposed on the liner 110 (block 154 ), as discussed above.
- the electrodes 16 and conductors 84 may include a conductive ink composition that is refurbished according to block 302 of method 300 above.
- FIGS. 21-23 each illustrate embodiments of methods corresponding to block 302 for replenishing the conductive inks of the electrodes 16 and/or conductors 84 .
- FIG. 21 illustrates an embodiment of a method 302 A that includes cleaning the portions of the electrodes 16 and/or conductors 84 that are exposed during remanufacture (block 310 ).
- the acts represented by block 310 may include ensuring that all adhesive and foam materials are removed from the electrodes 16 and conductors 84 .
- the electrodes 16 may be wiped or washed clean, for example to remove any remaining conductive gel 96 and/or remnants of the adhesive foam dots 104 .
- the conductive ink contained within the exposed portions may be re-ionized (block 312 ).
- the re-ionization step may involve re-chloridating the exposed conductive ink to increase the concentration of metal salt contained within the conductive ink composition.
- the re-chloridation may be performed using half cell potentials.
- the half cell reaction may be used to oxidize the silver to produce silver ions (e.g., Ag to Ag + ).
- any reaction capable of re-ionizing the conductive ink of the electrodes 16 and/or conductors 84 may be performed in accordance with block 312 , that, in certain embodiments, a half cell reaction may be desirable to avoid damaging or contaminating other portions of the sensor 12 , such as the adhesives 64 , 66 , the foam layer 62 , or the base structural layer 60 .
- half-cell reactions may generally be selective for metallic materials. Therefore, in the present context, a half cell reaction performed in accordance with block 312 may be selective for the used electrodes 16 and/or conductors 84 .
- the conductive ink of the used electrodes 16 and/or conductors 84 may be partially removed or no longer suitable for refurbishment after various remanufacturing steps have been performed. Accordingly, a new conducive ink 316 may be disposed over the used electrodes 16 and/or conductors 84 , an embodiment of which is illustrated in FIG. 22 . Specifically, FIG. 22 depicts the new conductive ink 316 as disposed directly on top of the used electrodes 16 and/or conductors 84 and in direct electrical contact with the conductive gel 96 , and under the adhesive foam dot 104 .
- the new conductive ink 316 may not be positioned under the adhesive foam dot 104 .
- the new conductive ink 316 may include the same conductive ink composition utilized in the used electrodes 16 and/or conductors 84 . Therefore, in one embodiment, the new conductive ink 316 may include a mixture of Ag/AgCl.
- the embodiment of the sensor 12 illustrated in FIG. 22 may be produced using either of methods 302 B of FIG. 23 or 302 C of FIG. 25 , which involve disposing the new conductive ink 316 over the used electrodes 16 and/or conductors 84 .
- method 302 B includes cleaning the exposed portions of the used electrodes 16 and/or conductors 84 (block 310 ), as discussed above with respect to FIG. 21 .
- the new conductive ink 316 may be provided (block 320 ).
- the new conductive ink 316 may be provided as a liquid ink mixture pre-loaded into a printing cartridge (e.g., for ink jet printing), in a bottle or other liquid-containing vessel, or as a liquid contained within a plastic enclosure (e.g., an ink dot) that is able to be ruptured to release the new conductive ink 316 .
- the new conductive ink 316 may then be disposed over the exposed portions of the used electrodes 16 and/or conductors 84 (block 322 ).
- the new conductive ink 316 may be printed (e.g., flexographically or screen printed), painted, poured, or otherwise positioned and disposed over the used electrodes 16 and/or conductors 84 .
- FIG. 24 schematically depicts an example process 324 for producing the new conductive ink 316 from a metallic ink 326 .
- the metallic ink 326 may be disposed over the used electrodes 16 and/or conductors 84 .
- the metallic ink 326 may include a composition or solution of a metal in its reduced form, such as Ag.
- a reaction such as a half-cell reaction, may be performed to produce the new conductive ink 316 , which includes an oxidized form of the metal, such as Ag + , which may be used to perform BIS or other electrical measurements on a patient, as discussed above.
- FIG. 25 illustrates an embodiment of a method 302 C, which includes the process 324 of FIG. 24 .
- the method 302 C includes cleaning the exposed portions of the used electrodes 16 and/or conductors 84 (block 310 ), as discussed above with respect to FIG. 21 .
- the method 302 C also includes providing the metallic ink 326 (block 330 ), which as noted above may include a composition or other solution having at least one metal, such as Ag, Cu, or another metal.
- the metallic ink 326 may be provided as a solution in a container such as a bottle, dropper, or other storage and dispensing vessel.
- the metallic ink 326 may be provided as a dot, which may include the metallic ink 326 disposed within a plastic enclosure. The dot may be ruptured to release the metallic ink 326 .
- the metallic ink 326 may then be disposed over the exposed portions of the used electrodes 16 and/or conductors 84 (block 332 ).
- the metallic ink 316 may be printed (e.g., flexographically or screen printed), painted, poured, or otherwise positioned and disposed over the used electrodes 16 and/or conductors 84 .
- the metallic ink 326 may then be ionized (block 334 ), for example using a half cell reaction or other metal-oxidizing reaction, to produce the new conductive ink 316 .
- any reaction capable of ionizing the metallic ink 326 may be performed in accordance with block 334 .
- a half cell reaction may be desirable to avoid damaging or contaminating other portions of the sensor 12 , such as the adhesives 64 , 66 , the foam layer 62 , or the base structural layer 60 .
- FIGS. 26 , 27 , 29 , 30 , and 31 each illustrate embodiments of methods for refurbishing the memory unit 94 and/or the paddle connector 20 of the sensor 12 .
- Method 152 A of FIG. 26 includes removing the paddle connector 20 , which includes the memory unit 94 , from the sensor 12 (block 340 ).
- the paddle connector 20 may be removed from the cable 24 (e.g., a patient adapter cable) and the paddle connector 20 may also be removed from the sensor 12 .
- a new paddle connector 20 having the new memory unit 94 may be provided (block 342 ).
- the paddle connector 20 and/or new memory unit 94 may have the same or a similar configuration compared to the used memory unit 94 .
- the new memory unit 94 may include stored code that enables new or enhanced functionality for the sensor 12 (e.g., when connected to the monitor 14 ), such as increased patient history functionality and/or updated operational information that reflects any updates, upgrades, or other changes that have been made to the sensor 12 .
- new calibration data relating to their conductivity may be written to the memory unit 94 .
- the new paddle connector 20 and memory unit 94 may then be attached to the sensor 12 (block 344 ).
- FIG. 27 illustrates an embodiment of a method 152 B for re-programming the memory unit 94 .
- the method 152 B includes providing a memory alteration device (not shown) (block 350 ), which may include a computer or other processor-based device that is capable of accessing and deleting at least a portion of the data stored on the memory unit 94 .
- the memory alteration device may be an application-specific or a general-purpose computer having code configured to re-program the memory unit 94 contained within the paddle connector 20 .
- the memory alteration device may include one or more ports for coupling to the paddle connector 20 or to the memory unit 94 , or both.
- the paddle connector 20 and/or memory unit 94 may be coupled to the alteration device (block 352 ).
- the memory alteration device may include a port that couples to the paddle connector 20 through which the memory alteration device is able to access and re-program the memory unit 94 .
- the memory alteration device may include a port that specifically receives the memory unit 94 , such that the memory unit 94 may be removed from the paddle connector 20 and coupled directly to the memory alteration device for re-programming.
- the memory unit 94 may be cleared or otherwise re-programmed (block 354 ). For example, in embodiments where the memory unit 94 has time-out functionality that causes the sensor to become non-functional after a given number of connections, uses, or after a certain amount of time in operation, the memory alteration device may re-set the number of connections, uses, or time in operation to zero or another lower threshold value. Alternatively or additionally, in embodiments where the memory unit 94 contains stored patient or other historical data, the memory alteration device may clear the historical data. As noted above, in embodiments where the electrodes 16 and/or the conductors 84 are replaced, new or updated calibration data may be written to the memory unit 94 .
- sensor-related information may be written to the memory unit 94 , which may be displayed on the display of a monitor to which the sensor 12 may attach (e.g., the display 34 of the EEG monitor 14 ).
- the memory unit 94 may be programmed such that the type of sensor is displayed (e.g., the name or model number of the sensor).
- an indication that the sensor 12 has been remanufactured may be provided along with the type of sensor.
- the display 34 may read “Quattro-R,” with “Quattro” indicating the model of the sensor 12 and “-R” indicating that the sensor 12 is a remanufactured sensor.
- the memory unit 94 may be removed from the memory alteration device (block 356 ) and may be suitable for use in conjunction with a remanufactured sensor (i.e., sensor 12 ).
- a remanufactured sensor i.e., sensor 12
- the adapter 360 is coupled directly to the paddle connector 20 and the connector 22 of the cable 24 , though the adapter 360 may be configured to couple to a variety of connectors, such as a connector of the EEG monitor 14 .
- the embodiment of the sensor 12 illustrated in FIG. 28 may be produced by a method 152 C, which is illustrated in FIG. 29 .
- the method 152 C may include providing the adapter 360 for the memory unit 94 (block 370 ).
- the adapter 360 may be configured to manipulate data transmitted to the memory unit 94 such that the memory unit 94 receives data indicative of a reduced number of connections, a reduced operation time, and/or a reduced number of uses.
- the adapter may manipulate data transmitted from the memory unit 94 to the EEG monitor 14 such that the memory unit 94 transmits data indicative of a reduced number of connections, a reduced operation time, and/or a reduced number of uses to the EEG monitor 14 .
- the paddle connector 20 may be connected to the adapter 360 (block 372 ). Due to its mode of operation, as illustrated in FIG. 28 , the adapter 360 may be retained as a part of, or integral with, the paddle connector 20 (block 374 ).
- FIG. 30 illustrates an embodiment of such a method 152 D, which may be performed in conjunction with certain of the sensor remanufacturing methods described above, or may be performed independently.
- the method 152 D includes providing a memory emulator (not shown) and a replacement memory unit 94 (block 380 ).
- a memory emulator may include an application-specific or general purpose processor-based device (e.g., a computer) that is configured to interface with the original memory unit 94 and/or the paddle connector 20 that includes the memory unit 94 .
- the new memory unit 94 may include a memory device that is capable of being programmed in a similar manner to the original memory unit 94 , such as an erasable programmable read-only memory (EPROM).
- EPROM erasable programmable read-only memory
- the replacement or new memory unit 94 may also interface with the memory emulator such that the new memory unit 94 may be suitably programmed by the memory emulator to mimic the output of the original memory unit 94 .
- the used memory unit 94 may then be attached to the memory emulator (block 382 ).
- the memory emulator may include a memory interface, such that the used memory unit 94 is removed from the paddle connector 20 before coupling to the memory emulator.
- the paddle connector 20 may directly connect to the memory emulator.
- the memory emulator may attempt to automatically, or in conjunction with a technician, emulate the operation of the used memory unit 94 .
- the output of the used memory unit 94 may be analyzed, and the memory emulator may attempt to mimic or otherwise simulate the output of the used memory unit 94 .
- the new memory unit 94 may be programmed to emulate the configuration of the used memory unit 94 (block 384 ).
- the used memory unit 94 may be removed from the used/remanufactured sensor 12 (block 386 ).
- the used memory unit 94 may be removed from the paddle connector 20 , or the paddle connector 20 may be removed from the sensor 12 .
- the paddle connector 20 may be removed from the sensor 12 .
- the new memory unit 94 which emulates the operation of the used memory unit 94 , may be attached to the sensor 12 (block 388 ).
- the new memory unit 94 may be integrated into the paddle connector 20 .
- a new paddle connector 20 may be provided that includes the new memory unit 94 .
- FIG. 31 illustrates an embodiment of a method 390 for integrating a used paddle connector 20 and associated memory unit 94 with a new sensor.
- Method 390 includes obtaining the used version of the sensor 12 (block 122 ) as described above with respect to FIGS. 4 and 5 .
- the sensor 12 may be obtained after the sensing and memory components have been tested (e.g., from a testing facility), after the sensor 12 has been sterilized (e.g., from a sterilization facility), or after the sensor 12 has been used to monitor a patient (e.g., from a medical facility).
- the paddle connector 20 and memory unit 94 may then be removed (block 340 ) as described above with respect to FIG. 26 .
- the paddle connector 20 having the memory unit 94 may be removed from the tail portion 86 of the sensor 12 .
- the memory unit 94 may be remanufactured according to either of methods 152 B or 152 C described above.
- a new sensor may also be provided (block 392 ), such as a sensor having new electrodes 16 and conductors 84 , support layers, padding layers, and so forth. It may be appreciated that in embodiments where the memory unit 94 is remanufactured after being removed from the paddle connector 20 , that the new sensor may also include a new paddle connector 20 or another type of connector (e.g., a socket-based connector). The remanufactured memory unit 94 , or remanufactured memory unit 94 and paddle connector 20 (or other connector), may then be attached to the new sensor (block 394 ).
- FIG. 32 illustrates an embodiment of a modified sensor 400 , which includes various remanufactured components of the sensor 12 of FIG. 2 .
- the modified sensor 400 may have the same or a similar configuration as the sensors described in U.S. patent application Ser. No. 13/074,127 entitled “Method and System for Positioning a Sensor,” filed Mar. 28, 2011, which is incorporated by reference herein in its entirety.
- the modified sensor 400 may include a base material 402 , which may be configured to serve as a supporting structure for the remanufactured components of the sensor 12 .
- the remanufactured components may include components which have undergone any of the remanufacturing methods described above, such as the base structural layer 60 , the electrodes 16 , the conductors 84 , the memory unit 94 and paddle connector 20 , the foam layer 62 , or any combination thereof.
- the base structural layer 400 may include rubber or elastomeric compositions (including acrylic elastomers, polyimide, silicones, silicone rubber, celluloid, PMDS elastomer, polyurethane, polypropylene, acrylics, nitrile, PVC films, acetates, and latex) to facilitate stretching and conformance to the patient, while the base structural layer 60 of the used sensor 12 may include non-elastomeric, flexible materials such as select polyethylene, polyester or polypropylene plastics. Indeed, it may be desirable to integrate the components of the used sensor 12 into the base material 402 of the modified sensor 400 to provide enhanced conformance and attachment to the patient. Indeed, the modified sensor 400 may include an adhesive 404 disposed on the base material 402 to enable the base material 402 to also secure to the patient.
- rubber or elastomeric compositions including acrylic elastomers, polyimide, silicones, silicone rubber, celluloid, PMDS elastomer, polyurethane, polypropylene, acrylics, nitrile
- the modified sensor 400 may include, in a similar manner to the used sensor 12 , a plurality of electrode portions 406 A- 406 D, which may each have a different or the same shape as the electrode portions 76 of the sensor 12 illustrated in FIG. 2 . In the embodiment illustrated in FIG. 32 , however, the plurality of electrode portions 406 A- 406 D may be shaped such that the electrode portions 76 are modified to form new electrode portions 407 A-D.
- the modified sensor 400 may also include a stretchable bridge 408 connecting the electrode portion 406 A with the electrode portion 406 B. The stretchable bridge 408 may surround the bridge 72 , and may be configured enable a varied distance d 1 between the electrodes 16 A and 16 B.
- the stretchable bridge 408 may have an elasticity that is greater than the bridge 72 . Accordingly, the bridge 72 may be folded to accommodate the variance in d 1 .
- the stretchable bridge 408 may also include notches 410 that enable rotational movement to allow the electrode 16 A to be correctly positioned.
- a method 420 for producing the modified sensor 400 of FIG. 32 is illustrated in FIG. 33 .
- the method 420 includes obtaining the used sensor 12 (block 122 ), as discussed above with respect to FIGS. 4 and 5 .
- the used sensor 12 may be sterilized (block 422 ), for example using EtO gas, Pasteurization, autoclaving, disinfecting solutions, gamma irradiation, or the like.
- the used sensor 12 may then be disassembled (block 424 ), for example by separating the components of the sensor 12 in the manner illustrated in FIG. 2 . However, certain components may be kept coupled together.
- the base structural layer 60 may remain coupled to the paddle connector 20 and the foam layer 62 .
- the patient-contacting adhesive 66 may be replaced to enable the portion of the modified sensor 400 proximate the foam layer 62 to be secured to the patient.
- Materials used to produce the modified sensor 400 may be obtained (block 426 ).
- the base material 402 , additional foam materials, conductive gel 96 , and the like, may be obtained.
- the configuration of the modified sensor 400 may be reviewed, and the used components of the sensor 12 may be remanufactured (block 428 ).
- the base structural layer 60 may be re-sized to fit within the base material 402 .
- the electrode portions 76 of the sensor 12 illustrated in FIG. 2 , may be cut so as to form electrode portions 407 A-D, which are configured to conform to the shape and size of the electrode portions 406 of the modified sensor 400 .
- the memory unit 94 may be refurbished according to any of methods 152 A-D discussed above, and the electrodes 16 and/or conductors 84 may be replenished according to any of methods 302 A-C discussed above.
- the refurbished components may be integrated with the new materials of the modified sensor 400 (block 430 ).
- the base structural layer 60 of the used sensor 12 may be disposed on or within, or adhered to the base material 402 .
- new foam or another padding material may be integrated with the base structural layer to provide padding and comfort to the patient.
- the conductive gel 96 may also be provided as a part of the modified sensor 400 , or may be provided in a dispenser for use when the modified sensor 400 is used for patient monitoring.
- final assembly steps may be performed to complete the modified sensor 400 assembly process (block 462 ).
- various adhesives, markings, or the like may be disposed on the base material 402 such that the modified sensor 400 is ready for patient monitoring.
- the modified sensor 400 may then be placed on the liner 110 (block 154 ) for future testing, packaging, and delivery to a medical facility.
Abstract
Description
- The present disclosure relates generally to remanufactured medical devices and, more particularly, to remanufacturing sensors used for sensing physiological parameters of a patient.
- This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.
- In the field of medicine, doctors often desire to monitor certain physiological characteristics of their patients. Accordingly, a wide variety of devices have been developed for monitoring certain physiological characteristics of a patient. Such devices provide doctors and other healthcare personnel with the information they need to provide the best possible healthcare for their patients. As a result, such monitoring devices have become an indispensable part of modern medicine.
- One technique for monitoring certain physiological characteristics of a patient is commonly referred to as electroencephalography (EEG), and the devices built based upon electroencephalographic techniques are commonly referred to as EEG monitors. EEG monitors use non-invasive electrophysiological monitoring to evaluate global changes in a patient's condition, for example, during surgical procedures. Examples of global changes may include assessing the effects of anesthetics, evaluating asymmetric activity between the left and right hemispheres of the brain in order to detect cerebral ischemia, and detecting burst suppression. One such technique includes bispectral index (BIS) monitoring to measure the level of consciousness by algorithmic analysis of a patient's EEG during general anesthesia.
- EEG measurements are captured using EEG monitoring devices, and sensors associated with these monitoring devices are applied to the patient. Typically, the sensors include electrodes that may be applied to various anatomies of the patient (e.g., the temple and/or forehead). For example, sensors for BIS monitoring may include a single strip that includes several electrodes for placement on the forehead to noninvasively acquire an EEG signal. Because the BIS sensors are placed in direct contact with a patient, and possibly patient fluids, BIS sensors are typically intended for use with a single patient. Thus, BIS sensors are typically discarded after use.
- Advantages of the disclosed techniques may become apparent upon reading the following detailed description and upon reference to the drawings in which:
-
FIG. 1 is a front view of an embodiment of a monitoring system configured to be used with a sensor for performing BIS measurements, in accordance with an aspect of the present disclosure; -
FIG. 2 is an exploded perspective view of an embodiment of the sensor ofFIG. 1 , in accordance with an aspect of the present disclosure; -
FIG. 3 is a schematic representation of an embodiment of the sensor ofFIG. 2 in packaged form, in accordance with an aspect of the present disclosure; -
FIG. 4 is a process flow diagram of an embodiment of a general method for remanufacturing the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 5 is a process flow diagram of an embodiment of a method for remanufacturing the sensor ofFIGS. 1-3 , including refurbishing the body of the sensor, in accordance with an aspect of the present disclosure; -
FIG. 6 is a process flow diagram of an embodiment of a method for removing and replacing features disposed within electrode wells of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 7 is a process flow diagram of an embodiment of a method for removing and replacing features disposed within electrode wells of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 8 is a process flow diagram of an embodiment of a method for removing and replacing features disposed within electrode wells of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 9 is a process flow diagram of an embodiment of a method for removing and replacing features disposed within electrode wells of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 10 is a cross-sectional view, taken along line 10-10, of an embodiment of the sensor ofFIGS. 1-3 having a self-supporting conductive gel, in accordance with an aspect of the present disclosure; -
FIG. 11 is a process flow diagram of an embodiment of a method for removing features disposed within electrode wells of the sensor ofFIGS. 1-3 and replacing the features with the self-supporting conductive gel ofFIG. 10 , in accordance with an aspect of the present disclosure; -
FIG. 12 is a process flow diagram of an embodiment of a method for remanufacturing a body of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 13 is a cross-sectional view, taken along line 10-10, of an embodiment of the sensor ofFIGS. 1-3 having multiple foam layers, in accordance with an aspect of the present disclosure; -
FIG. 14 is a process flow diagram of an embodiment of a method for remanufacturing a body of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 15 is a process flow diagram of an embodiment of a method for remanufacturing a body of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 16 is a cross-sectional view, taken along line 10-10, of an embodiment of the sensor ofFIGS. 1-3 having an additional patient-contacting adhesive disposed over a used patient-contacting adhesive, in accordance with an aspect of the present disclosure; -
FIG. 17 is a process flow diagram of an embodiment of a method for remanufacturing a body of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 18 is an exploded perspective view of an embodiment of the sensor ofFIGS. 1-3 and illustrating a plurality of patient-contacting layers laminated over a foam layer of the sensor, in accordance with an aspect of the present disclosure; -
FIG. 19 is a process flow diagram of an embodiment of a method for remanufacturing a body of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 20 is a process flow diagram of an embodiment of a method for remanufacturing the sensor ofFIGS. 1-3 including replenishing the conductive ink of the electrodes and/or conductors of the sensor, in accordance with an aspect of the present disclosure; -
FIG. 21 is a process flow diagram of an embodiment of a method for replenishing the conductive ink of the electrodes and/or conductors of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 22 is a cross-sectional view, taken along line 10-10, of an embodiment of the sensor ofFIGS. 1-3 having a new conductive ink disposed over a used conductive ink, in accordance with an aspect of the present disclosure; -
FIG. 23 is a process flow diagram of an embodiment of a method for replenishing the conductive ink of the electrodes and/or conductors of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 24 is a schematic depiction of an embodiment of a process for ionizing a metallic ink disposed on the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 25 is a process flow diagram of an embodiment of a method for replenishing the conductive ink of the electrodes and/or conductors of the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; -
FIG. 26 is a process flow diagram of an embodiment of a method for refurbishing the memory unit of the sensor ofFIGS. 1-3 , including replacing the connector of the sensor, in accordance with an aspect of the present disclosure; -
FIG. 27 is a process flow diagram of an embodiment of a method for refurbishing the memory unit of the sensor ofFIGS. 1-3 , including re-programming the memory unit contained within the connector of the sensor, in accordance with an aspect of the present disclosure; -
FIG. 28 is a front view of an embodiment of the sensor ofFIGS. 1-3 having an adapter coupled to the connector for altering the operability of the memory unit, in accordance with an aspect of the present disclosure; -
FIG. 29 is a process flow diagram of an embodiment of a method for refurbishing the memory unit of the sensor ofFIGS. 1-3 , including providing an adaptor for the time-out feature contained within the connector of the sensor, in accordance with an aspect of the present disclosure; -
FIG. 30 is a process flow diagram of an embodiment of a method for refurbishing memory unit of the sensor ofFIGS. 1-3 , including emulating the memory unit on a new memory unit, in accordance with an aspect of the present disclosure; -
FIG. 31 is a process flow diagram of an embodiment of a method for remanufacturing the sensor ofFIGS. 1-3 including retaining only the connector and memory unit and replacing the used sensor with a new sensor, in accordance with an aspect of the present disclosure; -
FIG. 32 is a front view of an embodiment of a sensor having new components and remanufactured components from the sensor ofFIGS. 1-3 , in accordance with an aspect of the present disclosure; and -
FIG. 33 is a process flow diagram of an embodiment of a method for remanufacturing the sensor ofFIGS. 1-3 to produce the sensor ofFIG. 32 , in accordance with an aspect of the present disclosure. - One or more specific embodiments of the present techniques will be described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.
- The present disclosure is generally directed to the remanufacturing of bispectral index (BIS) sensors having one or more electrodes for monitoring brain activity of a patient. For example, the sensors described herein may include one or more electrodes, such as at least two electrodes, for capturing electrical data from a patient's brain, and features for facilitating the capture and transmittal of the data from the patient to a patient monitor. Thus, the BIS sensors described herein may be constructed using a combination of new materials (i.e., materials that have not been incorporated into a BIS sensor) and components taken from one or more used BIS sensors (e.g., an electrode). For example, a BIS sensor may include a base layer supporting a flexible array of electrodes configured to capture electrical data from a patient, a conductive gel to facilitate the transmission of the electrical signals from the patient to the sensor, one or more foam pieces to pad the BIS sensor, and an adhesive layer for attaching the sensor to the patient, such as to the patient's forehead and/or temple. Accordingly, BIS sensors constructed using the remanufacturing techniques described herein may incorporate used foam layers, flexible circuits, and, in certain embodiments, existing but unused adhesive layers, or any combination thereof.
- By way of example, a BIS™ sensor available from Aspect Medical Systems, Inc., such as a BIS™ Quattro sensor, a BIS™ extend sensor, a BIS™ pediatric sensor, or a BIS™ bilateral sensor, which include a plurality of printed electrodes on a flexible substrate, represent one type of EEG sensor. It should be noted, however, that the present disclosure is applicable to any EEG or similar sensor having similar or the same materials and/or configuration as those described herein. Further, other sensors having some or all of the components described herein (e.g., ECG sensors, general EEG sensors, pulse oximetry sensors, or sensors used for measuring water fraction or hematocrit) may benefit from the disclosed techniques. The BIS sensors disclosed herein may be used in conjunction with any suitable monitoring system, which is described with respect to
FIG. 1 . An example BIS sensor and its components are discussed with respect toFIG. 2 , and a packaged EEG sensor is discussed with respect toFIG. 3 . As noted above, these sensors are generally known to be one-time-use sensors that may be discarded after use by one patient. Though disposable, some components of these used sensors, such as the conductors, connectors, and memory units associated therewith, may be employed in the construction of remanufactured sensors. Reusing these components to reconstruct a sensor may reduce waste (e.g., plastic waste materials), consequently reducing an impact on the environment, while accordingly reducing costs. Various embodiments of remanufacturing techniques and the configurations that result are discussed with respect toFIGS. 4-33 . - With the foregoing in mind,
FIG. 1 is a front view of an embodiment of apatient monitoring system 10. Themonitoring system 10 may include asensor 12 and anEEG monitor 14. Thesensor 12 may include electrodes 16 (e.g., fourelectrodes flexible sensor body 18 to provide enhanced flexibility and conformance to patient tissue. Thesensor 12 may include apaddle connector 20, which couples through aconnector 22 to a cable 24 (e.g., a patient interface cable), which in turn may be coupled to a cable 26 (e.g., a pigtail cable). In certain embodiments, thesensor 12 may be coupled to thecable 26 thereby eliminating thecable 24. Thecable 26 may be coupled to adigital signal converter 28, which in turn is coupled to the cable 30 (e.g., a monitor interface cable). In certain embodiments, thedigital signal converter 28 may be embedded in themonitor 14 to eliminate thecables Cable 26 may be coupled to themonitor 14 via a port 32 (e.g., a digital signal converter port). - The
monitor 14 may be capable of calculating physiological characteristics relating to the EEG signal received from thesensor 12. For example, the monitor may be capable of algorithmically calculating BIS from the EEG signal. BIS is a measure of a patient's level of consciousness during general anesthesia. Further, themonitor 14 may include adisplay 34 capable of displaying physiological characteristics, historical trends of physiological characteristics, other information about the system (e.g., instructions for placement of thesensor 12 on the patient), and/or alarm indications. Themonitor 14 may display a patient'sBIS value 36. TheBIS value 36 represents a dimensionless number (e.g., ranging from 0, i.e., silence, to 100, i.e., fully awake and alert) output from a multivariate discriminate analysis that quantifies the overall bispectral properties (e.g., frequency, power, and phase) of the EEG signal. For example, aBIS value 36 between 40 and 60 may indicate an appropriate level for general anesthesia. Themonitor 14 may also display a signal quality index (SQI) bar graph 38 (e.g., ranging from 0 to 100) which measures the signal quality of the EEG channel source(s) based on impedance data, artifacts, and other variables. Themonitor 14 may yet also display an electromyograph (EMG) bar graph 40 (e.g., ranging from 30 to 55 decibels) which indicates the power (e.g., in decibels) in the frequency range of 70 to 110 Hz. The frequency range may include power from muscle activity and other high-frequency artifacts. Themonitor 14 may further display a suppression ratio (SR) 42 (e.g., ranging from 0 to 100 percent), which represents the percentage of epochs over a given time period (e.g., the past 63 seconds) in which the EEG signal is considered suppressed (i.e., low activity). In certain embodiments, themonitor 14 may also display a burst count for the number of EEG bursts per minute, where a “burst” is defined as a short period of EEG activity preceded and followed by periods of inactivity or suppression. Themonitor 14 may yet further display theEEG waveform 44. In certain embodiments, theEEG waveform 42 may be filtered. Themonitor 14 may stillfurther display trends 46 over a certain time period (e.g., one hour) for EEG, SR, EMG, SQL and/or other parameters. In certain embodiments, themonitor 14 may display stepwise instructions for placing thesensor 12 on the patient. In addition, themonitor 14 may display a verification screen verifying the proper placement of each electrode 16 of thesensor 12 on the patient. In certain embodiments, themonitor 14 may store instructions on a memory specific to a specific sensor type or model, which is discussed in further detail below. In other embodiments, thesensor 12 may include a memory that provides the instructions to themonitor 14. - Additionally, the
monitor 14 may include various activation mechanisms 48 (e.g., buttons and switches) to facilitate management and operation of themonitor 14. For example, themonitor 14 may include function keys (e.g., keys with varying functions), a power switch, adjustment buttons, an alarm silence button, and so forth. It should be noted that in other embodiments, the parameters described above and theactivation mechanisms 48 may be arranged on different parts of themonitor 14. In other words, the parameters andactivation mechanisms 48 need not be located on afront panel 50 of themonitor 14. Indeed, in some embodiments,activation mechanisms 48 are virtual representations in a display or actual components disposed on separate devices. In addition, theactivation mechanisms 48 may allow selecting or inputting of a specific sensor type or model in order to access instructions stored within the memory of thesensor 12. - One embodiment of the various components of the
sensor 12 is illustrated with respect toFIG. 2 , which may generally represent the BIS™ Quattro sensor, the BIS™ extend sensor, the BIS™ pediatric sensor, or the BIS™ bilateral sensor mentioned above. For example, the embodiment of thesensor 12 illustrated inFIG. 2 may represent a BIS™ Quattro sensor, whereinelectrode 16A is configured to function as a sensing electrode,electrode 16B is configured to monitor artifacts resulting from muscular movement, such as eye twitching,electrode 16C is configured to function as a grounding electrode, andelectrode 16D is configured to function as a reference electrode. It should be noted that in certain embodiments, thesensor 12 may be capable of performing BIS measurements with fewer than four electrodes 16, or more than four electrodes 16. For example, in one embodiment, thesensor 12 may be capable of performing BIS measurements usingonly electrodes sensor 12 is a BIS™ bilateral sensor, the electrodes 16 may include a reference electrode configured to be placed at the center of the patient's forehead, two electrodes each configured to be placed above an eye of the patient to monitor artifacts from eye twitching or movement, one ground electrode, and two electrodes each configured to be placed against the patient's temples for monitoring. - As illustrated, the
sensor 12 includes a basestructural layer 60, afoam layer 62, a first adhesive 64 configured to secure thefoam layer 62 to the basestructural layer 60, and a patient-contactingadhesive 66 configured to secure thesensor 12 to a patient. The basestructural layer 60 may be constructed from any flexible polymeric material suitable for use in medical devices, such as polyester, polyurethane, polypropylene, polyethylene, polyvinylchloride, acrylics, nitrile, PVC films, acetates, or similar materials that facilitate conformance of thesensor 12 to the patient. On the other hand, thefoam layer 62 may be relatively rigid compared to the basestructural layer 60 to provide padding and additional comfort to the patient. As an example, thefoam layer 62 may include any foam material suitable for use in medical applications, such as polyester foam, polyethylene foam, polyurethane foam, or the like. Thefirst adhesive 64 and the patient-contactingadhesive 66 may include pressure sensitive adhesives such as an acrylic-based adhesive, a supported transfer tape, an unsupported transfer tape, or any combination thereof. In certain embodiments, the patient-contactingadhesive 66 may include a hydrocolloid or similar adhesive for patients with sensitive skin. It should be noted that thefoam layer 62 andadhesives foam layer 62 and theadhesives adhesives foam layer 62 and theadhesives respective tabs layer foam layers adhesives sensor body 18, which is the structural support in which the features for collecting EEG-related data from the patient are disposed. - The
sensor body 18 may be configured to facilitate proper placement of thesensor 12 on a patient's head. For example, thesensor body 18 may include afirst body portion 68 and asecond body portion 70 that are joined by athin bridge 72 of the basestructural layer 60, and are separated by adiscontinuation 74 in thefoam layer 62 andadhesives structural layer 60 may be constructed from a flexible polymeric material, thebridge 72 is able to bend with a relatively high degree of freedom (e.g., compared to the foam layer 62). In certain configurations, theelectrodes first body portion 68, may be placed on a patient's forehead, whileelectrode 16A, which is located on thesecond body portion 70, is placed on the patient's temple. Therefore, because thebridge 72 can easily bend, thesensor 12 is able to accommodate a variety of distances between the forehead and temple areas (i.e., head sizes) by enabling thesensor 12 to arch, twist, or flex between the first andsecond body portions - It should be noted that the illustrated placement of the
bridge 72 is only one embodiment, and that thebridge 72 may be placed between other electrodes 16 in other configurations. For example, in embodiments where thesensor 12 is a BIS™ pediatric sensor or similar sensor, thebridge 72 may be between theelectrode 16B and theelectrode 16C rather than the illustrated placement. Further, thesensor 12 may include more than onebridge 72, such as two ormore bridges 72 disposed between the electrodes 16 (e.g., in a BIS™ bilateral sensor). Furthermore, a length l1 of thebridge 72 may be varied depending on the end use of the sensor 12 (e.g., pediatric, small, regular, or large sizes). Alternatively or additionally, as discussed below, thesensor 12 may not include a bridge portion and may include configurations similar to those described in U.S. patent application Ser. No. 13/074,127 entitled “Method and System for Positioning a Sensor,” filed Mar. 28, 2011, which is incorporated by reference herein in its entirety for all purposes. - The base
structural layer 60 of thesensor 12 also includes a plurality of electrode portions 76 each having a particular shape. The shape of the electrode portions 76 may be configured to facilitate retention of thesensor 12 on the patient, and, more specifically, to maintain pressure of the corresponding electrode 16 on the electrode portion 76 against the patient's forehead or temple. As illustrated, the electrodes 16 are generally positioned at the center of their respective electrode portion 76. The shapes of the electrode portions 76 may also be reflected in the shape of thefoam layer 62 and theadhesives foam layer 62 and theadhesives structural layer 60. Thefoam layer 62 and theadhesives respective holes - As will be appreciated, the electrodes 16 are constructed from conductive materials to enable the
sensor 12 to perform electrical measurements on the patient. Specifically, in accordance with certain embodiments, the electrodes 16 are formed from flexible conductive materials, such as one or more conductive inks. For example, the electrodes 16 may be produced by printing (e.g., screen printing or flexographic printing) a conductive ink on the basestructural layer 60 and allowing the ink to dry and/or cure. In certain embodiments, the ink may be thermally cured. Thesensor 12 may also include a plurality ofconductors 84 disposed (e.g., screen or flexographically printed) on the basestructural layer 60 to transmit signals to and from each of the electrodes 16 and to enhance flexibility of thesensor 12. Theconductors 84 may be formed from the same or a different conductive ink than the electrodes 16. Suitable conductive inks for the electrodes 16 and theconductors 84 may include inks having one or more conductive materials such as metals (e.g., copper (Cu) or silver (Ag)) and/or metal ions (e.g., silver chloride (AgCl)), filler-impregnated polymers (e.g., polymers mixed with conductive fillers such as graphene, conductive nanotubes, metal particles), or any ink having a conductive material capable of providing conductivity at levels suitable for performing the EEG or other electrical measurements. As an example, the electrodes 16 and/orconductors 84 may be formed from an ink having a mixture of Ag and AgCl. Indeed, in certain embodiments, silver and salts thereof (e.g., Ag/AgCl) may be desirable to use for the electrodes 16 andconductors 84 due to its enhanced stability (e.g., compared to copper and copper salts) during certain medical procedures, such as defibrillation. For example, the Ag/AgCl may enable the sensor to depolarize within a desired amount of time (e.g., seconds rather than minutes). This depolarization within a short amount of time may enable thesensor 12 to be used a short time after the defibrillation or similar procedure. However, in a general sense, any suitable conductive material may be used for the electrodes 16 and theconductors 84. - The
conductors 84, as noted above, are generally configured to transmit signals to and/or from the electrodes 16. Thus, theconductors 84 may be configured transmit signals such as power, data, and the like, collected at or transmitted to each of the electrodes 16 to or from atail portion 86 of the basestructural layer 60. Thetail portion 86 of the basestructural layer 60 includes aninterface region 88 in which thesensor 12 is configured to couple to another connector or themonitor 14 to enable themonitor 14 to perform BIS measurements. Additionally, thetail portion 86 may be a flat, flexible protrusion from thebody portion 18 of thesensor 12 to enable thesensor 12 to be worn by the patient with minimal discomfort by reducing the bulk and weight of thesensor 12 on the patient. - The
tail portion 86 and thepaddle connector 20 interface with one another at respective overlappingconnection regions sensor 12 to physically couple to theconnector 22 or themonitor 14 ofFIG. 1 . As an example, thepaddle connector 20 may be configured to enable thesensor 12 to clip into theconnector 22 and/or themonitor 14. Thepaddle connector 20 may also include amemory unit 94 configured to store information relating to thesensor 12, and to provide the stored information to themonitor 14. For example, thememory unit 94 may store code configured to provide an indication to themonitor 14 as to the make/model of thesensor 12, the time-in-operation of thesensor 12, the number of times thesensor 12 has been remanufactured, or the like. Alternatively or additionally, thememory unit 94 may include code configured to perform a time-out function where thesensor 12 is deactivated after a predetermined number of connections, time-in-operation, or similar use-related metric. In certain embodiments, thememory unit 94 may also store patient-specific and/or sensor-specific information such as trend data collected by the electrodes 16, calibration data related to the electrodes 16 and/orconductors 84, and so on. In other words, thememory unit 94 may be configured to enable thesensor 12 to be used in conjunction with themonitor 14 for the collection of patient data. - As noted, the
sensor 12 may be kept in electrical contact with the patient for the collection of EEG or similar data. Accordingly, thesensor 12 may also include aconductive gel 96 configured to conduct electrical signals between the electrodes 16 and the patient tissue. Generally, theconductive gel 96 may include a wet gel or a hydrogel that is compatible with the materials used for the electrodes 16 and theconductors 84. Theconductive gel 96 may include a salt (e.g., sodium chloride (NaCl) or potassium chloride (KCl)) having an ionic concentration suitable for conducting electrical signals between the patient and the electrodes 16. For example, the concentration of chloride ions in theconductive gel 96 may be between approximately 2 and 10% by weight. - The
conductive gel 96 may be disposed within electrode wells (e.g.,FIG. 10 ) corresponding to each of the electrodes 16 and defined by the basestructural layer 60, thefoam layer 62, and theholes 78. As illustrated, theconductive gel 96 may be applied by a tube orpacket 98 over the corresponding position of the electrodes 16. However, as discussed below, in some embodiments theconductive gel 96 may be provided as a bubble of gel that is disposed in each electrode well and is configured to burst when applied to the patient. Further, in certain embodiments, theconductive gel 96 may have a viscosity that enables theconductive gel 96 to be self-supporting. In such embodiments, theconductive gel 96 may be the only material disposed within the electrode wells. However, in the illustrated embodiment, theconductive gel 96 may have a viscosity such that theconductive gel 96 may not remain within the electrode wells before thesensor 12 is applied to the patient. Accordingly, thesensor 12 may also include a series ofgel support structures 100 that are configured to support theconductive gel 96 in the sensor 12 (i.e., within each electrode well). In accordance with an embodiment, thegel support structures 100 may include an open cell foam sponge material configured to hold theconductive gel 96 within the wells. - The
gel support structures 100 may each be disposed over respective preparation surfaces 102, each of which include a series ofprotrusions 103. By way of example, the preparation surfaces 102 may include a plastic material, such as a plastic backing and associated set of protrusions produced by modification (e.g., shaving) of a hook portion of a hook and loop fastener. Theprotrusions 103 of the preparation surfaces 102 may prepare the patient for monitoring by penetrating the interface between the patient's skin and the electrodes 16. Thus, in certain embodiments, thesensor 12 may be considered to be a self-prepping sensor. The preparation surfaces 102 may be secured to the electrodes 16 byadhesive foam dots 104. Collectively, thegel support structures 100, the preparation surfaces 102, and theadhesive foam dots 104 may be referred to as electrode wellstructures 106. Theadhesive foam dots 104, which may be formed from the same or a different foam material than thefoam layer 62, attach directly to the electrodes 16. Generally, theadhesive foam dots 104 will have a cylindrical shape, though they may be any suitable shape and size. Theadhesive foam dots 104 may have a surface area at each axial extent that is smaller than a surface area of each electrode 16 such that a sufficient portion of the electrodes 16 are left uncovered to ensure suitable conductance between the electrodes 16 and the patient. Theadhesive foam dots 104 may be double-coated with adhesive, as illustrated, or may have discrete adhesive layers attached at each axial extent, as illustrated inFIG. 13 . In certain embodiments, thegel support structures 100 may be sized so as to be substantially flush with, or stand slightly proud of, thesensor body 18. - The components of the
sensor 12 described above may be assembled generally as illustrated inFIG. 2 , though other configurations may be possible, as discussed in detail below. After thesensor 12 is produced, thesensor 12 may be packaged and provided to a medical facility for use.FIG. 3 depicts an embodiment of the manner in which thesensor 12 may be packaged. As illustrated, thesensor 12 is placed on aliner 110, which may include a series ofindentations 112 for receiving each of thegel support structures 100. Theliner 110 may include any suitable lining material that is appropriate for use in conjunction with the materials of thesensor 12 and theconductive gel 96. As an example, theliner 110 may include a siloxane material, a polyethylene liner material, a polystyrene liner material, a polyester liner material, or the like. - The
sensor 12 andliner 110 are contained within apackaging 114. Thepackaging 114 may include a packaging material suitable for retaining the moisture of theconductive gel 96 when thesensor 12 is stored. That is, thepackaging 114 may prevent theconductive gel 96 of thesensor 12 from drying out, which could prevent thesensor 12 from having a suitable level of electrical conductivity with the patient. Accordingly, thepackaging 114 will generally have a moisture vapor transmission rate (MVTR) that is sufficiently low to prevent theconductive gel 96 from drying. As an example, thepackaging 114 may include metal barrier materials such as an aluminum foil material, polymeric barrier materials such as biaxially oriented polyethylene terephthalate (BoPET), a metalized barrier film (e.g., metalized PET), or any combination thereof. - As noted above, the
sensor 12 discussed with respect toFIGS. 1-3 may be manufactured from a combination of new, refurbished, and/or used materials. Indeed, the present embodiments provide various methods for remanufacturing EEG sensors, such as the BIS™ sensors mentioned above, in accordance with the configurations discussed above. For example,FIG. 4 illustrates a generalized sensor remanufacturing method,FIGS. 5-27 illustrate sensor remanufacturing methods for replacing and/or refurbishing various features of thesensor 12, andFIGS. 28-33 each illustrate a connector/memory unit remanufacturing method that can be performed in conjunction with or independently of the methods ofFIGS. 5-27 . - Referring now to
FIG. 4 , an embodiment of amethod 120 for remanufacturing a medical sensor (e.g., a BIS™ sensor), such as thesensor 12, is illustrated. The method begins with obtaining a used version of the sensor 12 (block 122). The used version of thesensor 12 may be a single-use medical sensor (i.e., for use on a single patient) or may be a reusable sensor. Thesensor 12 may be obtained, as an example, by a technician or similar manufacturing personnel. Thesensor 12 may be sterilized before or after the acts represented byblock 122 such that thesensor 12 is suitable for handling by a technician or similar worker. Thesensor 12 may also undergo inspection and/or testing to determine the operability of the sensor 12 (block 124). As an example, in embodiments where thesensor 12 is a BIS™ sensor, the testing may include testing the operation and accuracy of the electrodes 16, thepaddle connector 20, thesensor cable 24, and any other electronic features of thesensor 12, such as thememory unit 94. - After the
sensor 12 has been inspected and tested, it may be determined whether it is appropriate to remanufacture the sensor (query 126). For example, it may be determined whether thesensor 12 includes suitable components for remanufacture (e.g., by reviewing the results of the sensor testing acts ofblock 124 and/or visual inspection). Alternatively or additionally, it may be determined whether thesensor 12 has undergone previous iterations of remanufacturing. Accordingly, thesensor 12 may include one or more indications as to whether thesensor 12 has been previously remanufactured, such an external mark on thesensor 12 or a counter stored on thememory unit 94. For example, thememory unit 94 may track the number of times thesensor 12 has undergone sterilization procedures (e.g., ethylene oxide (EtO) gas, gamma irradiation, autoclaving, chemical sanitation, Pasteurization), memory clearing, memory re-programming, and the like. - In embodiments where remanufacture is not appropriate, the used version of the
sensor 12 may be discarded (block 128). For example, one or more features of the used version of thesensor 12 may be inoperative, such as thepaddle connector 20, thecable 24, and so on. Depending on the degree to which thesensor 12 may be inoperative, it may no longer be cost-effective to remanufacture, and thesensor 12 may be discarded. In other embodiments, as mentioned above, thesensor 12 may have an external mark or a stored counter that indicates that thesensor 12 is not suitable for remanufacture. Indeed, as discussed herein, the external markings and/or the counter on thememory unit 94 may be incremented with each remanufacturing procedure. - Conversely, in embodiments where it is determined that at least a portion of the
sensor 12 is suitable for remanufacturing, thesensor 12 may be remanufactured according to certain remanufacturing processes (block 130). For example, in embodiments where thesensor 12 includes at least some viable components (e.g., thebase support layer 60, the electrodes 16 andconductors 84, thepaddle connector 20, the memory unit 94), or has one or more indications via thememory unit 94 and/or external marks that remanufacturing is suitable, thesensor 12 may be remanufactured. Embodiments of certain remanufacturing processes are discussed below. - After the
sensor 12 has been remanufactured, thesensor 12 is then tested to ensure that it is within certain operational tolerances (block 132). For example, thesensor 12 may be attached or otherwise coupled to a test rig, which may determine and, if suitable, adjust varying operational parameters of thesensor 12. For example, various sensor-specific information may be stored on thememory unit 94, such as conductance-related data if the electrodes 16 and/orconductors 84 are refurbished, information pertaining to the sensor 12 (e.g., the name of thesensor 12, a model code for the sensor 12), or the like. Thesensor 12 may then be packaged (block 134) and sent to a medical facility for use. - Because portions of the
sensor body 18 may contact patient tissue and possibly bodily fluids, it may be desirable, in some situations, to refurbish at least a portion of thesensor body 18 during refurbishment of thesensor 12. Additionally or alternatively, in embodiments where the used version of thesensor 12 includes thememory unit 94, thememory unit 94 may also be refurbished. Accordingly,FIG. 5 illustrates an embodiment of amethod 140 for remanufacturing thesensor 12 that includes refurbishing portions of thesensor body 18 and thememory unit 94. Themethod 130 may include obtaining a used version of the sensor 12 (block 122), which may generally correspond to the acts described above with respect toFIG. 4 . That is, thesensor 12 may be obtained directly from a medical facility or from a third party that may obtain thesensor 12 directly or indirectly from a medical facility. Once thesensor 12 is obtained, thesensor 12 may be prepared for remanufacturing (block 124) by sterilization or other preparation steps, as discussed above with respect toFIG. 4 . - After the
sensor 12 has been prepared for remanufacturing, at least a portion of the electrodes 16 of thesensor 12 may be exposed (block 142). For example, thegel support structures 100, the preparation surfaces 102, theadhesive foam dots 104, or any combination thereof, may be removed from the electrode wells to expose the electrodes 16. In certain embodiments, thegel support structures 100 and the preparation surfaces 102 may be removed from theadhesive foam dots 104 such that only a portion of the electrodes 16 are exposed. - Because the
conductive gel 96 may also contact the patient and may not be entirely removed when performing the acts represented byblock 142, theconductive gel 96 may be removed from the sensor 12 (block 144). For example, theconductive gel 96 may be removed from thesensor 12 using an aqueous solution (e.g., water, deionized water, or water with a surfactant) to dissolve theconductive gel 96, compressed air to blow theconductive gel 96 out, theconductive gel 96 may simply be wiped out using a cloth or the like, or any combination thereof. In certain embodiments, theconductive gel 96 may be removed using chemical solutions other than aqueous solutions (e.g., organic-based solutions), though it should be noted that it may be desirable to avoid solvents that may undesirably dissolve thebase support layer 60 and/or thefoam layer 62. Further, in embodiments where a solution is used to remove theconductive gel 96, a drying step may also be performed to remove any remaining liquid from thesensor 12. - Before, during, or after removing the
conductive gel 96 from thesensor 12, thefoam layer 62 and theadhesive layers FIGS. 13-20 . Once the foam layers andadhesive layers block 142 may be replaced. Embodiments of the manner in which the portion of thesupport structures 100 are removed in accordance withblock 142 and replaced in accordance withblock 148 are discussed in further detail below with respect toFIGS. 6-12 . - After the
gel support structures 100 and the preparation surfaces 102 are in place, theconductive gel 96 is provided (block 150). The acts represented byblock 150 may include disposing theconductive gel 96 over the electrodes 16, or providing theconductive gel 96 in a separate dispenser so as to allow a caregiver (e.g., a clinician, nurse, doctor) to dispose theconductive gel 96 in thesensor 12 just before use. In some embodiments, discussed with respect toFIGS. 10 and 11 , theconductive gel 96 may have a viscosity sufficient so as to allow thesensor 12 to be used without thegel support structures 100. - The
memory unit 94 may also be refurbished (block 152). For example, thememory unit 94 may be cleared, re-programmed, replaced, or the like. Embodiments relating to refurbishing thememory unit 94, such as by replacing or re-programming thememory unit 94, are discussed in further detail below with respect toFIGS. 27-32 . Before, during, or after refurbishing thememory unit 94, thesensor 12 may be placed on the liner 110 (block 154). For example, in embodiments where theconductive gel 96 is disposed in thesensor 12, thesensor 12 may be placed on theliner 110 shortly after disposing theconductive gel 96 in thesensor 12 to help retain theconductive gel 96. - As noted above, the
gel support structures 100, the preparation surfaces 102, theadhesive foam dots 104, or any combination thereof, may be removed and/or replaced during remanufacture of thesensor 12. One embodiment of amethod 160 for refurbishing the electrode well supportingstructures 100 is illustrated inFIG. 6 . Themethod 160 may include removing the preparation surfaces 102 and theadhesive foam dots 104 from the electrodes 16 (block 162). For example, the preparation surfaces 102 may be removed from theadhesive foam dots 104, and theadhesive foam dots 104 may be removed from thesensor 12 by shaving, peeling, or pulling theadhesive foam dots 104 away from the electrodes 16. Because theadhesive foam dot 104 may be damaged or otherwise unsuitable for use in theremanufactured sensor 12, a newadhesive foam dot 104 may be provided (block 164). - In certain situations, the
gel support structures 100 and the preparation surfaces 102 may be removed from thesensor 12 before theconductive gel 96 is removed (e.g., in block 144 ofFIG. 5 ). Accordingly, theconductive gel 96 may also be removed from thegel support structures 100 and the preparation surfaces 102 (block 166). For example, as discussed above with respect to block 144 ofFIG. 5 , theconductive gel 96 may be removed by washing with water, soapy water, another aqueous solution, an organic chemical solution, by wiping, by blowing with compressed air, or any combination thereof. In certain embodiments, because theconductive gel 96 trapped within the electrodewell support structures 100 and/or the preparation surfaces 102 may contain debris from a previous use, the either or both may be separately sanitized using EtO gas, autoclaving, Pasteurization, gamma irradiation, or any other suitable sterilization technique known in the art. Thegel support structures 100, the preparation surfaces 102, and the newadhesive foam dots 104 may then be disposed on the electrodes 16 (block 168). - As mentioned above, the
adhesive foam dots 104 may be damaged during removal in accordance withblock 164 ofFIG. 6 . Accordingly, it may be desirable to leave theadhesive foam dots 104 within thesensor 12 while removing thegel support structures 100 and the preparation surfaces 102.FIG. 7 illustrates an embodiment of amethod 170 in which the usedadhesive foam dots 104 are retained within thesensor 12. Themethod 170 includes removing thegel support structures 100 and the preparation surfaces 102 while leaving theadhesive foam dots 104 attached to the electrodes 16 (block 172). Theconductive gel 96 may then be removed from thegel support structures 100 and the preparation surfaces 102 in accordance withblock 166 described above. The cleanedgel support structures 100 and the preparation surfaces 102 may then be re-adhered to the adhesive foam dots 104 (block 174). - Rather than performing steps to clean the
gel support structures 100 and the preparation surfaces 102, it may be desirable to simply replace thegel support structures 100 and the preparation surfaces 102 with new materials.FIG. 8 illustrates an embodiment of onesuch method 180 for replacing the electrode wellstructures 106. Themethod 180 includes removing the electrode wellstructures 106 from the electrodes 16 (block 162), as discussed above with respect toFIG. 6 . New electrode wellstructures 106 may be provided (block 182). It should be noted that the new electrode wellstructures 106 may be the same or different than the used versions, depending on cost of replacement or other considerations, such as new or improved materials, or the like. The new electrode wellstructures 106 may then be adhered to the electrodes 16 (block 184). - While replacing the entirety of the electrode well
structures 106 during remanufacture may be performed as described above, it may be desirable to only replace thegel support structures 100 and the preparation surfaces 102.FIG. 9 illustrates one embodiment of such amethod 190. Themethod 190 includes removing thegel support structures 100 and the preparation surfaces 102 from the adhesive foam dots 104 (block 172) as described above with respect toFIG. 7 . Newgel support structures 100 and the preparation surfaces 102 may be provided (block 192), which may be the same or different than the usedgel support structures 100 and the preparation surfaces 102. The newgel support structures 100 and the preparation surfaces 102 may then be adhered to the adhesive foam dots 104 (block 194). - As noted above, the electrode well
structures 106 are generally configured to support theconductive gel 96 within thesensor 12 so as to retain theconductive gel 96 within thesensor 12, and also to prepare the patient for monitoring as thesensor 12 is attached to the patient's forehead and temple (or other somatic region). However, in certain embodiments, theconductive gel 96 may have a sufficient viscosity so as to preclude the use of thegel support structures 100.FIG. 10 is a cross-section of thesensor 12 taken along line 10-10, and illustrates one such embodiment where theconductive gel 96 is self-supporting within an electrode well 200 of thesensor 12. InFIG. 10 , thesensor 12 does not include thegel support structures 100. In certain embodiments where theconductive gel 96 is self-supporting, thesensor 12 may include theadhesive foam dot 104 and thepreparation surface 102. - The cross-section of
FIG. 10 also illustrates the self-supportingconductive gel 96 as in direct contact with the electrodes 16, which may be coextensive with theconductors 84. As illustrated, theconductors 84 are disposed underneath thefoam layer 62 while the electrodes 16 are exposed. An embodiment of amethod 210 for producing the embodiment of thesensor 12 ofFIG. 10 from the embodiment of thesensor 12 ofFIG. 2 is illustrated inFIG. 11 . Themethod 210 includes removing the electrode wellstructures 106 from the electrode wells 200 (block 162), as discussed above with respect toFIG. 6 . It should be noted that since the electrode wellstructures 106 are not retained in the remanufactured sensor, they may be discarded or repurposed, for example, for use in another sensor or other medical device. A newconductive gel 96 may be provided (block 212). The newconductive gel 96 may have a viscosity that is the same, or greater than theconductive gel 96 used in the usedsensor 12. For example, in embodiments where the newconductive gel 96 is more viscous, theconductive gel 96 may have a higher viscosity by having a lower concentration of water or other fluid, by having a polymer with a greater molecular weight, by having a polymer with a lower solubility, or the like. The viscousconductive gel 96 may then be disposed in the electrode wells 200 (block 214) in place of the electrode wellstructures 106. - As discussed above with respect to
FIG. 5 , thefoam layer 62 and theadhesive layers electrode wells 200 and the electrode wellstructures 106 according to the methods described above.FIGS. 12-19 depict embodiments of methods for refurbishing these layers, and the resulting configurations of thesensor 12. Specifically,FIGS. 12 , 14, 15, 17, and 18 each illustrate an embodiment of the acts represented byblock 146 ofFIG. 5 . -
FIG. 12 illustrates an embodiment of amethod 146A that includes replacing thefoam layer 62 andadhesives method 146A may begin by removing the existingfoam layer 62 and associatedadhesives structural layer 60 of the sensor 12 (block 220). For example, thesensor 12 may be warmed to reduce the adhesive bond strength of the firstadhesive layers 64 to facilitate separation of thefoam layer 62 away from the basestructural layer 60. In other embodiments, thefoam layer 62 andadhesives structural layer 60. In certain embodiments, theadhesives foam layer 62. However, it should be noted that the solvent may be selected so as to dissolve theadhesives foam layer 62 or basestructural layer 60. Conversely, in certain embodiments, thefoam layer 62 and associatedadhesives structural layer 60. - A
new foam layer 62 andadhesives new foam layer 62 may include the same or different materials compared to the usedfoam layer 62, and theadhesives adhesives foam layer 62 and the basestructural layer 60 may be selected so as to facilitate removal of thefoam layer 62 from the basestructural layer 60, for example to facilitate future remanufacturing processes. That is, the new version of the first adhesive 64 may have a lower adhesive bond strength compared to the used version of thefirst adhesive 64. The material used for the new version of the first adhesive 64 may have a reduced bonding strength compared to the used version. Alternatively or additionally, the new version of the first adhesive 64 may cover a smaller surface area of thefoam layer 62 such that the overall bond of thefoam layer 62 to the basestructural layer 60 is weaker compared to the used version of thesensor 12. Thenew foam layer 62 andadhesives structural layer 60 of the sensor 12 (block 224). - In some embodiments, it may be desirable to retain at least a portion of the used
foam layer 62 in theremanufactured sensor 12. For example, in some configurations, thefoam layer 62 may be difficult to remove from the basestructural layer 60 without damaging thesensor 12. Accordingly, thefoam layer 62 may be retained, at least in part.FIG. 13 is a cross-sectional view of an embodiment of thesensor 12 after removing a top portion (i.e., closer to the patient-contacting side) of thefoam layer 62 and disposing anadditional foam layer 230 over the usedfoam layer 62. To accommodate the size of theadditional foam layer 230, a thickness t1 of thefoam layer 62 may be reduced such thesensor 12 may have an optimal overall thickness. The illustratedsensor 12 also includes anew adhesive 232 configured to adhere theadditional foam layer 230 to the usedfoam layer 62, and a patient-contacting adhesive 234 disposed on theadditional foam layer 230 configured to adhere thesensor 12 to the patient. Theadditional foam layer 230 may include the same foam material as the usedfoam layer 62, may include different foam materials than the usedfoam layer 62, or a combination. Likewise, theadhesives adhesives - As noted above with respect to
FIG. 2 ,FIG. 13 also provides a cross-sectional view of the adhesive foam dot 104 disposed between first andsecond adhesives adhesive foam dot 104. Thefirst adhesive 236 is configured to adhere the adhesive foam dot 104 to the electrode 16, and thesecond adhesive 238 is configured to adhere the adhesive foam dot 104 to aplastic backing 240 of thepreparation surface 102. - An embodiment of a
method 146B for producing thesensor 12 ofFIG. 13 is illustrated inFIG. 14 . Themethod 146B includes removing a portion of the foam layer 62 (block 250), which may involve shaving, peeling, dissolving, etching, or otherwise separating a first portion of thefoam layer 62 away from a second portion of thefoam layer 62. It will be appreciated that in removing the portion of thefoam layer 62 that the patient-contactingadhesive 66 is removed as well. Theadditional foam layer 230 and theadhesives - While the embodiments described above relate to removing the
foam layer 62, it may be desirable to retain thefoam layer 62 and replace the outermost patient-contactingadhesive 66.FIG. 15 illustrates an embodiment of such amethod 146C in which the adhesive 66 is replaced. Themethod 146C includes removing the patient-contacting adhesive 66 from the foam layer 62 (block 260). For example, in embodiments where the patient-contactingadhesive 66 is a supported adhesive layer, the patient-contactingadhesive 66 may be removed by pulling on thetab 67 such that the patient-contactingadhesive 66 separates from thefoam layer 62. In other embodiments, the patient-contactingadhesive 66 may be scraped off, dissolved away, wiped off, or removed by any other suitable adhesive removal technique. A new patient-contactingadhesive 66 may be provided (block 262). The new patient-contactingadhesive 66 may be the same or different adhesive than the used patient-contactingadhesive 66, and may include an acrylic adhesive, a supported transfer tape, an unsupported transfer tape, or other suitable adhesive material. The patient-contactingadhesive 66 may then be adhered to the existing foam layer 62 (block 264). - Rather than removing the used patient-contacting
adhesive 66 as discussed above, as illustrated inFIG. 16 , it may be desirable to refurbish thesensor 12 by disposing a new patient-contacting adhesive 266 directly over the used patient-contactingadhesive 66. The new patient-contacting adhesive 266 may be the same or different than the used patient-contactingadhesive 66, and may be a supported or unsupported transfer tape, an adhesive coating, or any adhesive capable of attaching thesensor 12 to the patient. An embodiment of amethod 146D for producing thesensor 12 ofFIG. 16 is illustrated inFIG. 17 . Themethod 146D includes providing the new adhesive 266 (block 270), which may be a supported or an unsupported transfer tape layer, or an adhesive coating, as noted above. The new patient-contacting adhesive 266 may then be adhered to the used patient-contacting adhesive 66 (block 272), which may include laminating the new patient-contacting adhesive 266 on the used patient-contactingadhesive 66 or coating the new patient-contacting adhesive 266 on the used patient-contactingadhesive 66. - To facilitate future remanufacturing of the
sensor 12, it may be desirable to provide a plurality ofadhesive layers 280 disposed over thefoam layer 62, as illustrated inFIG. 18 . InFIG. 18 , the plurality ofadhesive layers 280 are positioned over thefirst electrode portion 76A of thesensor 12, though it should be noted thatFIG. 18 is generally representative of multipleadhesive layers 280 positioned over theentire sensor body 18. In certain embodiments, oneadhesive layer 280 may be removed after each patient use. For example, after a patient is monitored using thesensor 12, one of theadhesive layers 280 may be removed (e.g., during remanufacture) to expose a newadhesive layer 280. In some embodiments, the number ofadhesive layers 280 may be such that after theadhesive layers 280 are exhausted, thesensor 12 may no longer be suitable for remanufacture. Theadhesive layers 280 may also each include atab 282 to facilitate removal during remanufacture. In other embodiments, theadhesive layers 280 may enable thesensor 12 to be used on a single patient over several uses. Theadhesive layers 280 may include any adhesive material suitable for use in medical devices, such as acrylic-based adhesives, transfer tape adhesives, or the like. - One embodiment of a
method 146E for producing thesensor 12 ofFIG. 18 is illustrated inFIG. 19 . Themethod 146E includes removing the used patient-contactingadhesive layer 66 from the foam layer 62 (block 260), as discussed above with respect toFIG. 15 . For example, the used patient-contactingadhesive layer 66 may be pulled, shaved, dissolved, or otherwise separated from thefoam layer 62. It should be noted, however, that in some embodiments the used patient-contactingadhesive 66 may be retained. The plurality of newadhesive layers 266 may be provided (block 290) and adhered to the existingfoam layer 62 of the sensor 12 (block 292). - In addition to or in lieu of remanufacturing portions of the
body 18 of thesensor 12 as described above, it may be desirable to remanufacture other portions of thesensor 12, such as the electrodes 16 and/or theconductors 84. In accordance with certain embodiments of the present disclosure, as noted, the electrodes 16 andconductors 84 may include a conductive ink composition having a mixture of a conductive metal and metal ion, such as an Ag/AgCl mixture. Accordingly, refurbishing the electrodes 16 andconductors 84 may include re-printing, re-ionizing, or otherwise replenishing the conductive ink. While thesensor 12 may be refurbished without replenishing the conductive ink, it should be noted that the shelf life of thesensors 12 described herein may be greatly reduced when refurbishment of the electrodes 16 and/orconductors 84 is not performed. For example, the electrodes 16 andconductors 84 may have poor conductivity, a lack of impedance, or similar diminished electrical properties such that thesensor 12 may not be suitable for performing BIS measurements after a certain amount of time. Accordingly, in embodiments where the electrodes 16 andconductors 84 include a conductive ink as described above, it may generally be desirable to replenish the conductive ink during remanufacture of thesensor 12. - Indeed, an embodiment of a
general method 300 for remanufacturing thesensor 12 that includes remanufacturing the electrodes 16 and/orconductors 84 is illustrated inFIG. 20 . Themethod 300 includes several steps that are the same as those described above with respect toFIG. 5 . Accordingly, those steps are discussed using the same reference numerals as used inFIG. 5 . Indeed, themethod 300 includes the same acts represented byblocks FIG. 5 . Thus, as discussed above, the used version of thesensor 12 may be obtained (block 122), which may include obtaining thesensor 12 directly from a medical facility or from a third party that obtains the medical sensor, as discussed above. Thesensor 12 may be prepared for the remanufacturing process (block 124), for example by sterilizing thesensor 12, removing debris from the previously monitored patient, performing testing on thesensor 12, or any combination thereof. At least a portion of the electrodes 16 may be exposed (block 142), for example by removing at least a portion of the electrode wellstructures 106. Theconductive gel 96 may also be removed from the electrode wells 200 (block 144) by wiping, dissolution, blowing, or any combination thereof, as discussed above. Theadhesives foam layer 62 may also be refurbished (block 146), for example using the methods described above with respect toFIGS. 12 , 14, 15, 17, and 19. - The
method 300 also includes, as noted, refurbishing the electrodes 16 and/or the conductors 84 (block 302). As discussed in detail below with respect toFIGS. 21-25 , the electrodes 16 and/orconductors 84 may be refurbished by re-printing the conductive ink of the electrodes 16 and/orconductors 84, re-ionization of the conductive ink of the electrodes 16 and/orconductors 84 or printing a metallic ink and ionizing the metallic ink to produce the electrodes 16 and/orconductors 84. After the electrodes 16 and/orconductors 84 are refurbished, theconductive gel 96 may be provided (block 150), as discussed above. Thememory unit 94 may also be refurbished (block 152), and thesensor 12 may be disposed on the liner 110 (block 154), as discussed above. - As noted, the electrodes 16 and
conductors 84 may include a conductive ink composition that is refurbished according to block 302 ofmethod 300 above.FIGS. 21-23 each illustrate embodiments of methods corresponding to block 302 for replenishing the conductive inks of the electrodes 16 and/orconductors 84. Specifically,FIG. 21 illustrates an embodiment of amethod 302A that includes cleaning the portions of the electrodes 16 and/orconductors 84 that are exposed during remanufacture (block 310). For example, in embodiments where thefoam layer 62 andadhesives sensor 12, the acts represented byblock 310 may include ensuring that all adhesive and foam materials are removed from the electrodes 16 andconductors 84. However, in embodiments where only the electrodes 16 are exposed, such as when thefoam layer 62 is not removed, the electrodes 16 may be wiped or washed clean, for example to remove any remainingconductive gel 96 and/or remnants of theadhesive foam dots 104. - After the electrodes 16 and/or
conductors 84 that are exposed have been suitably cleaned, the conductive ink contained within the exposed portions may be re-ionized (block 312). For example, in embodiments where the conductive ink composition includes a metal chloride salt (e.g., AgCl), the re-ionization step may involve re-chloridating the exposed conductive ink to increase the concentration of metal salt contained within the conductive ink composition. By way of example, the re-chloridation may be performed using half cell potentials. Specifically, in embodiments where the conductive ink is silver-based, the half cell reaction may be used to oxidize the silver to produce silver ions (e.g., Ag to Ag+). It should be noted that while generally any reaction capable of re-ionizing the conductive ink of the electrodes 16 and/orconductors 84 may be performed in accordance withblock 312, that, in certain embodiments, a half cell reaction may be desirable to avoid damaging or contaminating other portions of thesensor 12, such as theadhesives foam layer 62, or the basestructural layer 60. For example, half-cell reactions may generally be selective for metallic materials. Therefore, in the present context, a half cell reaction performed in accordance withblock 312 may be selective for the used electrodes 16 and/orconductors 84. - In some situations, the conductive ink of the used electrodes 16 and/or
conductors 84 may be partially removed or no longer suitable for refurbishment after various remanufacturing steps have been performed. Accordingly, a newconducive ink 316 may be disposed over the used electrodes 16 and/orconductors 84, an embodiment of which is illustrated inFIG. 22 . Specifically,FIG. 22 depicts the newconductive ink 316 as disposed directly on top of the used electrodes 16 and/orconductors 84 and in direct electrical contact with theconductive gel 96, and under theadhesive foam dot 104. However, it may be appreciated that in embodiments where theadhesive foam dot 104 is not removed during the remanufacturing process, that the newconductive ink 316 may not be positioned under theadhesive foam dot 104. The newconductive ink 316 may include the same conductive ink composition utilized in the used electrodes 16 and/orconductors 84. Therefore, in one embodiment, the newconductive ink 316 may include a mixture of Ag/AgCl. - The embodiment of the
sensor 12 illustrated inFIG. 22 may be produced using either ofmethods 302B ofFIG. 23 or 302C ofFIG. 25 , which involve disposing the newconductive ink 316 over the used electrodes 16 and/orconductors 84. Specifically,method 302B includes cleaning the exposed portions of the used electrodes 16 and/or conductors 84 (block 310), as discussed above with respect toFIG. 21 . The newconductive ink 316 may be provided (block 320). For example, the newconductive ink 316 may be provided as a liquid ink mixture pre-loaded into a printing cartridge (e.g., for ink jet printing), in a bottle or other liquid-containing vessel, or as a liquid contained within a plastic enclosure (e.g., an ink dot) that is able to be ruptured to release the newconductive ink 316. The newconductive ink 316 may then be disposed over the exposed portions of the used electrodes 16 and/or conductors 84 (block 322). For example, the newconductive ink 316 may be printed (e.g., flexographically or screen printed), painted, poured, or otherwise positioned and disposed over the used electrodes 16 and/orconductors 84. - While the new
conductive ink 316 may be provided as a pre-made conductive ink composition, it should be noted that in certain embodiments, the newconductive ink 316 may be produced during the remanufacturing process.FIG. 24 schematically depicts anexample process 324 for producing the newconductive ink 316 from ametallic ink 326. As illustrated, themetallic ink 326 may be disposed over the used electrodes 16 and/orconductors 84. Themetallic ink 326 may include a composition or solution of a metal in its reduced form, such as Ag. A reaction, such as a half-cell reaction, may be performed to produce the newconductive ink 316, which includes an oxidized form of the metal, such as Ag+, which may be used to perform BIS or other electrical measurements on a patient, as discussed above.FIG. 25 illustrates an embodiment of amethod 302C, which includes theprocess 324 ofFIG. 24 . - The
method 302C includes cleaning the exposed portions of the used electrodes 16 and/or conductors 84 (block 310), as discussed above with respect toFIG. 21 . Themethod 302C also includes providing the metallic ink 326 (block 330), which as noted above may include a composition or other solution having at least one metal, such as Ag, Cu, or another metal. Themetallic ink 326 may be provided as a solution in a container such as a bottle, dropper, or other storage and dispensing vessel. In certain embodiments, themetallic ink 326 may be provided as a dot, which may include themetallic ink 326 disposed within a plastic enclosure. The dot may be ruptured to release themetallic ink 326. Themetallic ink 326 may then be disposed over the exposed portions of the used electrodes 16 and/or conductors 84 (block 332). For example, themetallic ink 316 may be printed (e.g., flexographically or screen printed), painted, poured, or otherwise positioned and disposed over the used electrodes 16 and/orconductors 84. Themetallic ink 326 may then be ionized (block 334), for example using a half cell reaction or other metal-oxidizing reaction, to produce the newconductive ink 316. As noted above with respect toFIG. 21 , generally any reaction capable of ionizing themetallic ink 326 may be performed in accordance withblock 334. However, as noted above, a half cell reaction may be desirable to avoid damaging or contaminating other portions of thesensor 12, such as theadhesives foam layer 62, or the basestructural layer 60. - In addition to, or in lieu of, remanufacturing the
sensor body 18, the electrodes 16 and/or theconductors 84 in accordance with the methods described above, thememory unit 94 and thepaddle connector 20 may be refurbished according to various embodiments.FIGS. 26 , 27, 29, 30, and 31 each illustrate embodiments of methods for refurbishing thememory unit 94 and/or thepaddle connector 20 of thesensor 12.Method 152A ofFIG. 26 includes removing thepaddle connector 20, which includes thememory unit 94, from the sensor 12 (block 340). For example, referring to the embodiment illustrated inFIG. 1 , thepaddle connector 20 may be removed from the cable 24 (e.g., a patient adapter cable) and thepaddle connector 20 may also be removed from thesensor 12. - Once the
paddle connector 20 and associatedmemory unit 94 have been detached from thesensor 12, anew paddle connector 20 having thenew memory unit 94 may be provided (block 342). Thepaddle connector 20 and/ornew memory unit 94 may have the same or a similar configuration compared to the usedmemory unit 94. In some embodiments, thenew memory unit 94 may include stored code that enables new or enhanced functionality for the sensor 12 (e.g., when connected to the monitor 14), such as increased patient history functionality and/or updated operational information that reflects any updates, upgrades, or other changes that have been made to thesensor 12. For example, in embodiments where the electrodes 16 and/orconductors 84 are refurbished, new calibration data relating to their conductivity may be written to thememory unit 94. Thenew paddle connector 20 andmemory unit 94 may then be attached to the sensor 12 (block 344). - Because the
paddle connector 20 and associatedmemory unit 94 may represent a signification portion of the overall cost for eachsensor 12, it may be desirable to retain thepaddle connector 20 andmemory unit 94 and simply re-program thememory unit 94.FIG. 27 illustrates an embodiment of amethod 152B for re-programming thememory unit 94. Themethod 152B includes providing a memory alteration device (not shown) (block 350), which may include a computer or other processor-based device that is capable of accessing and deleting at least a portion of the data stored on thememory unit 94. Indeed, the memory alteration device may be an application-specific or a general-purpose computer having code configured to re-program thememory unit 94 contained within thepaddle connector 20. Furthermore, the memory alteration device may include one or more ports for coupling to thepaddle connector 20 or to thememory unit 94, or both. - After the memory alteration device is provided, the
paddle connector 20 and/ormemory unit 94 may be coupled to the alteration device (block 352). As noted above, the memory alteration device may include a port that couples to thepaddle connector 20 through which the memory alteration device is able to access and re-program thememory unit 94. Alternatively or additionally, the memory alteration device may include a port that specifically receives thememory unit 94, such that thememory unit 94 may be removed from thepaddle connector 20 and coupled directly to the memory alteration device for re-programming. - Once the
memory unit 94 is directly or indirectly coupled to the memory alteration device, thememory unit 94 may be cleared or otherwise re-programmed (block 354). For example, in embodiments where thememory unit 94 has time-out functionality that causes the sensor to become non-functional after a given number of connections, uses, or after a certain amount of time in operation, the memory alteration device may re-set the number of connections, uses, or time in operation to zero or another lower threshold value. Alternatively or additionally, in embodiments where thememory unit 94 contains stored patient or other historical data, the memory alteration device may clear the historical data. As noted above, in embodiments where the electrodes 16 and/or theconductors 84 are replaced, new or updated calibration data may be written to thememory unit 94. In certain embodiments, sensor-related information may be written to thememory unit 94, which may be displayed on the display of a monitor to which thesensor 12 may attach (e.g., thedisplay 34 of the EEG monitor 14). For example, thememory unit 94 may be programmed such that the type of sensor is displayed (e.g., the name or model number of the sensor). Further, an indication that thesensor 12 has been remanufactured may be provided along with the type of sensor. For example, for a disposable BIS™ Quattro sensor from Aspect Medical Systems, Inc. thedisplay 34 may read “Quattro-R,” with “Quattro” indicating the model of thesensor 12 and “-R” indicating that thesensor 12 is a remanufactured sensor. - After the
memory unit 94 is cleared and/or re-programmed, thememory unit 94 may be removed from the memory alteration device (block 356) and may be suitable for use in conjunction with a remanufactured sensor (i.e., sensor 12). However, rather than re-programming or replacing thememory unit 94 as set forth above, it may be desirable to use anadapter 360, as illustrated inFIG. 28 , that is configured to manipulate a data stream to and/or from thememory unit 94 to enable continued operation of thesensor 12, even after a predetermined number of connections, uses, and/or time has been exceeded. As illustrated inFIG. 28 , theadapter 360 is coupled directly to thepaddle connector 20 and theconnector 22 of thecable 24, though theadapter 360 may be configured to couple to a variety of connectors, such as a connector of theEEG monitor 14. The embodiment of thesensor 12 illustrated inFIG. 28 may be produced by amethod 152C, which is illustrated inFIG. 29 . - The
method 152C may include providing theadapter 360 for the memory unit 94 (block 370). Again, theadapter 360 may be configured to manipulate data transmitted to thememory unit 94 such that thememory unit 94 receives data indicative of a reduced number of connections, a reduced operation time, and/or a reduced number of uses. Alternatively or additionally, the adapter may manipulate data transmitted from thememory unit 94 to the EEG monitor 14 such that thememory unit 94 transmits data indicative of a reduced number of connections, a reduced operation time, and/or a reduced number of uses to theEEG monitor 14. Thepaddle connector 20 may be connected to the adapter 360 (block 372). Due to its mode of operation, as illustrated inFIG. 28 , theadapter 360 may be retained as a part of, or integral with, the paddle connector 20 (block 374). - In situations where the
original memory unit 94 components and/or the original programming for thememory unit 94 are not available, it may be desirable to emulate theoriginal memory unit 94. For example, it may be desirable to emulate theoriginal memory unit 94 using areplacement memory unit 94 that has been programmed to mimic the function of the original memory unit.FIG. 30 illustrates an embodiment of such amethod 152D, which may be performed in conjunction with certain of the sensor remanufacturing methods described above, or may be performed independently. - The
method 152D includes providing a memory emulator (not shown) and a replacement memory unit 94 (block 380). For example, a memory emulator may include an application-specific or general purpose processor-based device (e.g., a computer) that is configured to interface with theoriginal memory unit 94 and/or thepaddle connector 20 that includes thememory unit 94. Thenew memory unit 94 may include a memory device that is capable of being programmed in a similar manner to theoriginal memory unit 94, such as an erasable programmable read-only memory (EPROM). The replacement ornew memory unit 94 may also interface with the memory emulator such that thenew memory unit 94 may be suitably programmed by the memory emulator to mimic the output of theoriginal memory unit 94. The usedmemory unit 94, or the usedpaddle connector 20 having thememory unit 94, may then be attached to the memory emulator (block 382). For example, the memory emulator may include a memory interface, such that the usedmemory unit 94 is removed from thepaddle connector 20 before coupling to the memory emulator. In other embodiments, thepaddle connector 20 may directly connect to the memory emulator. - Once the used
memory unit 94 is directly or indirectly connected to the memory emulator, the memory emulator may attempt to automatically, or in conjunction with a technician, emulate the operation of the usedmemory unit 94. For example, the output of the usedmemory unit 94 may be analyzed, and the memory emulator may attempt to mimic or otherwise simulate the output of the usedmemory unit 94. Once the memory emulator has produced one or more routines that are able to suitably match the output of the usedmemory unit 94, thenew memory unit 94 may be programmed to emulate the configuration of the used memory unit 94 (block 384). - After the operation of the used
memory unit 94 is suitably emulated, the usedmemory unit 94 may be removed from the used/remanufactured sensor 12 (block 386). For example, the usedmemory unit 94 may be removed from thepaddle connector 20, or thepaddle connector 20 may be removed from thesensor 12. In embodiments where thememory unit 94 has already been removed from thepaddle connector 20 during the emulation process, thepaddle connector 20 may be removed from thesensor 12. Indeed, once the usedmemory unit 94 has been removed, thenew memory unit 94, which emulates the operation of the usedmemory unit 94, may be attached to the sensor 12 (block 388). For example, in embodiments where the usedmemory unit 94 has been removed from thepaddle connector 20, thenew memory unit 94 may be integrated into thepaddle connector 20. However, in embodiments where the usedpaddle connector 20 has been removed, anew paddle connector 20 may be provided that includes thenew memory unit 94. - Again, the
paddle connector 20 andmemory unit 94 may represent a considerable amount of the total cost of the sensors described herein. Indeed, while it may be cost-effective to remanufacture various portions of thesensor 12 including thesensor body 18, the electrodes 16 andconductors 84, it may be desirable to incorporate the usedmemory unit 94 and, in some embodiments, thepaddle connector 20, into a new sensor, such as thesensor 12 or another type of sensor. With this in mind,FIG. 31 illustrates an embodiment of amethod 390 for integrating a usedpaddle connector 20 and associatedmemory unit 94 with a new sensor. -
Method 390 includes obtaining the used version of the sensor 12 (block 122) as described above with respect toFIGS. 4 and 5 . For example, thesensor 12 may be obtained after the sensing and memory components have been tested (e.g., from a testing facility), after thesensor 12 has been sterilized (e.g., from a sterilization facility), or after thesensor 12 has been used to monitor a patient (e.g., from a medical facility). Thepaddle connector 20 andmemory unit 94 may then be removed (block 340) as described above with respect toFIG. 26 . For example, thepaddle connector 20 having thememory unit 94 may be removed from thetail portion 86 of thesensor 12. - Before or after removal of the
paddle connector 20 from thesensor 12, thememory unit 94 may be remanufactured according to either ofmethods - A new sensor may also be provided (block 392), such as a sensor having new electrodes 16 and
conductors 84, support layers, padding layers, and so forth. It may be appreciated that in embodiments where thememory unit 94 is remanufactured after being removed from thepaddle connector 20, that the new sensor may also include anew paddle connector 20 or another type of connector (e.g., a socket-based connector). Theremanufactured memory unit 94, orremanufactured memory unit 94 and paddle connector 20 (or other connector), may then be attached to the new sensor (block 394). - Rather than producing a sensor of the same type or configuration as the
sensor 12 ofFIG. 2 using the remanufacturing embodiments described herein, it may be desirable to integrate one or more remanufactured components of thesensor 12 into a different sensor design.FIG. 32 illustrates an embodiment of a modifiedsensor 400, which includes various remanufactured components of thesensor 12 ofFIG. 2 . Indeed, the modifiedsensor 400 may have the same or a similar configuration as the sensors described in U.S. patent application Ser. No. 13/074,127 entitled “Method and System for Positioning a Sensor,” filed Mar. 28, 2011, which is incorporated by reference herein in its entirety. - Specifically, the modified
sensor 400 may include abase material 402, which may be configured to serve as a supporting structure for the remanufactured components of thesensor 12. The remanufactured components may include components which have undergone any of the remanufacturing methods described above, such as the basestructural layer 60, the electrodes 16, theconductors 84, thememory unit 94 andpaddle connector 20, thefoam layer 62, or any combination thereof. The basestructural layer 400 may include rubber or elastomeric compositions (including acrylic elastomers, polyimide, silicones, silicone rubber, celluloid, PMDS elastomer, polyurethane, polypropylene, acrylics, nitrile, PVC films, acetates, and latex) to facilitate stretching and conformance to the patient, while the basestructural layer 60 of the usedsensor 12 may include non-elastomeric, flexible materials such as select polyethylene, polyester or polypropylene plastics. Indeed, it may be desirable to integrate the components of the usedsensor 12 into thebase material 402 of the modifiedsensor 400 to provide enhanced conformance and attachment to the patient. Indeed, the modifiedsensor 400 may include an adhesive 404 disposed on thebase material 402 to enable thebase material 402 to also secure to the patient. - The modified
sensor 400 may include, in a similar manner to the usedsensor 12, a plurality ofelectrode portions 406A-406D, which may each have a different or the same shape as the electrode portions 76 of thesensor 12 illustrated inFIG. 2 . In the embodiment illustrated inFIG. 32 , however, the plurality ofelectrode portions 406A-406D may be shaped such that the electrode portions 76 are modified to formnew electrode portions 407A-D. The modifiedsensor 400 may also include astretchable bridge 408 connecting theelectrode portion 406A with theelectrode portion 406B. Thestretchable bridge 408 may surround thebridge 72, and may be configured enable a varied distance d1 between theelectrodes stretchable bridge 408 may have an elasticity that is greater than thebridge 72. Accordingly, thebridge 72 may be folded to accommodate the variance in d1. Thestretchable bridge 408 may also includenotches 410 that enable rotational movement to allow theelectrode 16A to be correctly positioned. - A
method 420 for producing the modifiedsensor 400 ofFIG. 32 is illustrated inFIG. 33 . Themethod 420 includes obtaining the used sensor 12 (block 122), as discussed above with respect toFIGS. 4 and 5 . The usedsensor 12 may be sterilized (block 422), for example using EtO gas, Pasteurization, autoclaving, disinfecting solutions, gamma irradiation, or the like. The usedsensor 12 may then be disassembled (block 424), for example by separating the components of thesensor 12 in the manner illustrated inFIG. 2 . However, certain components may be kept coupled together. For example, the basestructural layer 60 may remain coupled to thepaddle connector 20 and thefoam layer 62. Other components, such as the foam the patient-contactingadhesives 66 and/or the electrode well supportingstructures 100, may be removed. The patient-contactingadhesive 66 may be replaced to enable the portion of the modifiedsensor 400 proximate thefoam layer 62 to be secured to the patient. - Materials used to produce the modified
sensor 400 may be obtained (block 426). For example, thebase material 402, additional foam materials,conductive gel 96, and the like, may be obtained. The configuration of the modifiedsensor 400 may be reviewed, and the used components of thesensor 12 may be remanufactured (block 428). For example, the basestructural layer 60 may be re-sized to fit within thebase material 402. As illustrated inFIG. 32 , the electrode portions 76 of thesensor 12, illustrated inFIG. 2 , may be cut so as to formelectrode portions 407A-D, which are configured to conform to the shape and size of the electrode portions 406 of the modifiedsensor 400. Further, thememory unit 94 may be refurbished according to any ofmethods 152A-D discussed above, and the electrodes 16 and/orconductors 84 may be replenished according to any ofmethods 302A-C discussed above. - After refurbishment of the desired components of the used
sensor 12, the refurbished components may be integrated with the new materials of the modified sensor 400 (block 430). For example, the basestructural layer 60 of the usedsensor 12 may be disposed on or within, or adhered to thebase material 402. Further, new foam or another padding material may be integrated with the base structural layer to provide padding and comfort to the patient. Theconductive gel 96 may also be provided as a part of the modifiedsensor 400, or may be provided in a dispenser for use when the modifiedsensor 400 is used for patient monitoring. - Once the remanufactured components have been integrated with the new sensor materials of the modified
sensor 400, final assembly steps may be performed to complete the modifiedsensor 400 assembly process (block 462). For example, various adhesives, markings, or the like may be disposed on thebase material 402 such that the modifiedsensor 400 is ready for patient monitoring. The modifiedsensor 400 may then be placed on the liner 110 (block 154) for future testing, packaging, and delivery to a medical facility. - While the disclosure may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the embodiments provided herein are not intended to be limited to the particular forms disclosed. Rather, the various embodiments may cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the following appended claims.
Claims (25)
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